Method and apparatus for antegrade transcatheter valve repair or implantation

ABSTRACT

Methods, apparatuses, and systems for performing a valve replacement or repair. Apparatuses may include systems and may include an outer catheter, one or more interchangeable inner catheters, a guidewire and an expandable chordae tendinae deflector. Also described herein are rapid pacing sheaths that may be used with any of these apparatuses and methods.

CLAIM OF PRIORITY

This patent application claims priority as a continuation-in-part toU.S. patent application Ser. No. 17/962,450, filed Oct. 7, 2022, andherein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The methods and apparatuses described herein may be related totranscatheter aortic valve implantation procedures. More specifically,the methods and apparatuses described herein may relate to apparatusesthat may enable a surgeon to implant an aortic valve into a patient'sheart using an antegrade approach to the aorta.

BACKGROUND

Heart valve surgeries may encompass a variety of surgical approachesused to repair or replace diseased heart valves. Some heart valvesurgeries may be open-heart procedures conducted under generalanesthesia. An incision is made through the patient's sternum(sternotomy), and the patient's heart is stopped while blood flow isrerouted through a heart-lung bypass machine. This valve replacementsurgery is a highly invasive procedure and is associated significantattendant risks and complications.

Transcatheter aortic valve replacement (TAVR) is one alternative to anopen-heart surgical aortic valve replacement. The aortic valve islocated between the left ventricle and the aorta. If the aortic valvedoes not operate correctly, blood flow from the heart to the body may beimpaired. In this procedure, a collapsed replacement aortic valve isdelivered to the implantation site through a catheter. The catheter istypically inserted into a patient's artery through an incision away fromthe heart. Using the catheter, a surgeon guides the replacement valveinto place, in a retrograde approach. After confirming the position ofthe replacement valve, the surgeon implants the valve using thecatheter.

Retrograde TAVR procedures (e.g., advancing the catheter in a directionopposite to or opposing blood flow) are often used because of a muchsimpler pathway for the catheter to approach the aortic valve. However,retrograde approaches may be associated with negative outcomes, such asmajor bleeding at the arterial access site or stroke from embolic debrisfrom the aorta, particularly when the patient's aortic valve suffersfrom stenosis and/or may include calcification or other deposits.Antegrade TAVR procedures (e.g., advancing the catheter in the directionof blood flow) via a transseptal approach may overcome some of thedisadvantages associated with retrograde TAVR procedures, by usingvenous access to reduce bleeding, and eliminating trauma to the aorticarch, to reduce stroke. Unfortunately, antegrade TAVR procedures havehistorically been more difficult to perform. Difficulties include a needfor an atrial septal crossing, possible damage to the mitral valve, andproblems related to delivering a large-profile implantation devicethrough the left atrium to the left ventricle and the aortic valve.These challenges have caused antegrade TAVR procedures to be largelysupplanted by other approaches.

Thus, there has been a long felt need for a method and apparatus ofperforming successful antegrade TAVR procedures.

SUMMARY OF THE DISCLOSURE

Described herein are apparatuses, systems, and methods to perform anantegrade aortic valve replacement. Example apparatuses (which mayinclude systems, system devices, and/or software) may include an outercatheter, an inner catheter (or multiple interchangeable innercatheters) and a guidewire. Any of the inner catheters may be detachablycoupled to the outer catheter. The inner catheter and outer catheter maysurround the guidewire such that the inner and outer catheters may beadvanced in a monorail fashion within the patient.

Any of the apparatuses and methods described herein may be configured topass safely through the mitral valve without engaging the interstices ofthe chordae tendinae. For example, any of these methods and apparatusesmay include an expandable deflector (e.g., an expandable balloon, cage,mesh, plurality of struts, etc.) that may be expanded to pass throughthe mitral valve orifice without engagement of the chordae tendinaewithin the left ventricle. In any of these methods and apparatuses thedeflector may deflect the device away from the chordae tendinae.

Any of these apparatuses and methods described herein may include arapid pacing sheath that is configured to apply a heart pacingstimulation during the procedure to allow pacing for bradycardia and/orrapid pacing to allow safe aortic valve deployment. Thus, theseapparatuses may be configured to apply rapid pacing or escape pacing.

In general, these apparatuses (e.g., systems) are configured to navigatethe venous vasculature cardiac anatomy for antegrade delivery of a heartvalve (e.g., an aortic valve, a mitral valve, etc.). By utilizing avenous delivery these apparatuses are configured to prevent scraping ofthe aortic and arterial vasculature which may cause complications whenrepairing a heart valve from the retrograde direction, as this mayrelease material (including clot and/or atherosclerotic material) mayresult in complications. Thus, these apparatuses may generally includean outer catheter having a distal end region that sealingly andreleasably mates with a slightly proximal region of the innercatheter(s) to prevent any gaps between the two when engaged. The outerand/or inner catheter(s) may also be configured to be bent or steeredfrom a region that is proximal to the distal end. The inner catheter(s)may include a steerable, pre-bent, and/or bendable (deflectable) regionthat is positioned between a tapered distal end region and a moreproximal sealing region that engages the inner catheter with the distalend of the outer catheter. This steerable, pre-bent and/or bendableregion may be configured to provide a very sharp bend (e.g., betweenabout 30 and about 180 degrees of deflection (e.g., between about 40-180degrees, between about 60-180, between about 80-180, between about90-180 degrees, between about 100-180 degrees, between about 110-180degrees, between about 120-180 degrees, greater than 120 degrees, etc.).In addition, the outer catheter may be particularly flexible andthin-walled, to allow it to track over the curves or bends formed by theinner catheter and track over the guidewire.

For example, a system for antegrade delivery of a replacement valve(e.g., aortic valve) that may include an outer catheter and an innercatheter comprising: a distal end region that is tapered, an engagementsurface proximal to a distal end of the inner catheter, wherein theengagement surface is configured to detachably couple to a distal endregion of the outer catheter so that an outer surface of the first innercatheter is flush with an outer surface of the outer catheter without agap, and a bend region between the engagement surface and the distal endthat is configured to assume a bend of greater than 120 degrees.

For example, a system for antegrade delivery of a replacement mitralvalve may include an outer catheter and an inner catheter comprising: adistal end region that is tapered, an engagement surface proximal to adistal end of the inner catheter, wherein the engagement surface isconfigured to detachably couple to a distal end region of the outercatheter so that an outer surface of the first inner catheter is flushwith an outer surface of the outer catheter without a gap, and a bendregion between the engagement surface and the distal end that isconfigured to assume a bend of greater between about 60 and 120 degrees.

Any of these apparatuses and methods may be configured for repair of avalve, not limited to replacement of the valve. For example, any ofthese methods may be for insertion of repair tools, implants, etc. Ingeneral, the same apparatuses and procedures for using them describedherein for valve replacement may be used for access and repair.

The distal end region may taper from a large proximal opening to anarrow distal opening (e.g., may taper from about 3 Fr or smaller toabout 14 Fr or larger, e.g., 20 Fr or larger, etc.).

As mentioned, the outer catheter may comprise a thin-walled flexibleouter layer of 14 Fr or larger that is configured to track with theinner catheter when the inner catheter is in a bent configuration. Theouter catheter may comprise a pre-bent distal region. In some examplesthe outer catheter may be bendable.

The inner catheter may be steerable (e.g., controllablybendable/deflectable). For example in some examples the inner catheterincludes a tendon or wire (e.g., pull wire) configured to bend the bendregion. The wire may be attached at the distal end of the bending distalregion. The distal region may include flexures (e.g., cut-outs, creases,etc.) to provide a predictable bending region. In any of these examplesthe bend region may comprise a bend setting material, such as a shapememory material (e.g., a nickel titanium alloy) that is configured toassume a bend. The bend region may be manually bent (shape set) prior touse to assume a bend once deployed out of the outer catheter and intothe vasculature. This bendable inner catheter may impart a major bend tothe distal portion of the flexible outer catheter to allow therelatively large outer catheter to track through the mitral valve, andor around the left ventricle to the left ventricular outflow track.

Any of the apparatuses described herein may include a second innercatheter comprising: a distal end region that is tapered, an engagementsurface proximal to a distal end of the inner catheter, wherein theengagement surface is configured to detachably couple to a distal endregion of the outer catheter so that an outer surface of the first innercatheter is flush with an outer surface of the outer catheter without agap, and a bend region between the engagement surface and the distal endthat is configured to assume a bend of greater than 30 degrees. Thus,the second (or subsequent) inner catheter may be similar to the firstinner catheter but may have a different bend angle or range of bendangles.

In any of the systems described herein the inner catheter may have abend region that is between about 3-10 mm from the distal tip of theinner catheter. As mentioned, this bend region may be between thetapered distal tip region and a proximal region that engages with theouter catheter.

In general, the inner catheter(s) may include a rapid exchange monorailconnection for a guidewire. This may allow the inner catheters to berapidly exchanged within the outer catheters. In some examples the outercatheter does not include a rapid exchange monorail but may be enclosedalong its entire length. Any of these systems may include one or moreguidewires, e.g., a first guidewire and a second guidewire, wherein thefirst guidewire is stiffer than the second guidewire. It may alsoinclude a guidewire with side-holes to allow contrast injection in theproximal aorta to allow more precise valve positioning. In general,these apparatuses may include one or more hemostasis valve that iscoupled to or configured to couple to the outer catheter.

The inner catheter may have a decreasing stiffness along the distal endregion. In general, the distal end may be significantly more flexiblethan the proximal end.

In any of these apparatuses, the inner catheter may comprise a dilationballoon disposed near a distal end region of the inner catheter. Forexample, the dilation balloon may be configured to open and or widen anopening through the septum or other anatomic region.

The inner catheter may include a skived hypotube configured to have adecreasing stiffness in a distal direction. In any of these apparatuses,the inner catheter may include a first section and a second section, andwherein the first section includes a braid configured to provide kinkresistance and resistance to torsion and the second section includes aspiral coil configured to provide less stiffness than the braid. Thefirst section may be configured to have an outer diameter ofapproximately 25 French (Fr.) (e.g., between 14 Fr and 35 Fr, between 20Fr and 30 Fr, between 22 Fr, and 28 Fr, between 22 Fr and 30 Fr, etc.)and the second section may be configured to have an outer diameter ofapproximately 23 Fr (e.g., between 1-5 Fr smaller than the firstsection, etc.). For example, the first section may be configured to havean inner diameter of approximately 24 Fr. and the second section isconfigured to have an inner diameter of approximately 22 Fr. As TAVRvalve technology provides smaller delivery diameters, smaller sheathscan be used. The outer catheter may include a coupler configured toengage with a lock ring disposed on the first inner catheter.

Also described herein are methods for percutaneous antegrade deliveryand insertion (implantation) of a valve, such as an aortic valve. Thesemethods may use any of the systems described herein. For example, amethod for percutaneous antegrade delivery and implantation of a valvein a patient may include: advancing a first inner catheter that isdistally tapered through a transseptal puncture, wherein a region of thefirst inner catheter proximal to a distal end of the first innercatheter is annularly engaged to an outer catheter at a distal endregion of the outer catheter so that an outer surface of the first innercatheter is flush with an outer surface of the outer catheter without agap; deflecting the first inner catheter within the left atrium so thata distal end region of the first inner catheter assumes a first bend;advancing the outer catheter and either the first inner catheter or asecond inner catheter that has been exchanged for the first innercatheter so that the first or second inner catheter is in the leftventricle; advancing a guidewire out of the distal end of the first orsecond inner catheter and across a valve of the patient's heart;removing the first or second inner catheter, leaving the wire in place,and implanting a replacement valve in the patient's heart through theouter catheter.

In any of these methods, after advancing the guidewire out of the distalend of the first or second inner catheter, the first or second innercatheter within the left ventricle may be deflected so that the distalend region of the first or second inner catheter assumes a second bendand faces the patient's left ventricular outflow tract. Implanting thereplacement valve may include implanting an aortic valve. For example,implanting the replacement valve may comprise implanting a mitral valve.

For example, a method for percutaneous antegrade delivery andimplantation of a valve in a patient may include: advancing a firstinner catheter that is distally tapered through a trans-septal puncture,wherein a region of the first inner catheter proximal to a distal end ofthe first inner catheter is annularly engaged to an outer catheter at adistal end region of the outer catheter so that an outer surface of thefirst inner catheter is flush with an outer surface of the outercatheter without a gap; deflecting the first inner catheter within theleft atrium so that a distal end region of the inner catheter assumes afirst bend; advancing the outer catheter and either the first innercatheter or a second inner catheter that has been exchanged for thefirst inner catheter so that the first or second inner catheter is inthe left ventricle; deflecting the first or second inner catheter withinthe left ventricle so that the distal end region of the first or secondinner catheter assumes a second bend turns towards the left ventricularoutflow tract; advancing a guidewire out of the distal end of the firstor second inner catheter and across an aortic valve of the patient'sheart; removing the first or second inner catheter, leaving the wire inplace, and implanting a replacement aortic valve in the patient's heartthrough the outer catheter.

Any of these methods may include advancing the outer catheter and thefirst or second inner catheter so that the first or second innercatheter passes through an aortic valve of the patient's heart and atleast partially into the ascending aorta over a guidewire. Implantingthe replacement aortic valve in the patient's heart may includeimplanting the replacement valve through the outer catheter and over theguidewire. If the aortic valve is delivered with the outer catheteracross the aortic valve the outer catheter would be withdrawn in aproximal direction to “unsheathe” the valve prior to valve deployment.

Any of these methods may include advancing a second guidewire into theleft ventricle after the first inner catheter has assumed the firstbend. Implanting the replacement aortic valve may include advancing atranscatheter aortic valve replacement (TAVR) delivery system throughthe outer catheter.

In some examples the method may include expanding the trans-septalpuncture with an expandable member on an outer surface of the firstinner catheter. For example, the expandable member may comprise aballoon.

The first bend (e.g., of the inner catheter) may be at least about 30degrees (e.g., between about 30-100 degrees, between about 30-90degrees, between about 30-80 degrees, between about 30-70 degrees,between about 30-60 degrees, between about 3-45 degrees, etc.). Thesecond bend may be at least about 120 degrees (e.g., between about120-190 degrees, between about 120-180 degrees, between about 120-170degrees, between about 120-160 degrees, between about 120-150 degrees,between about 120-140 degrees, etc.). Deflecting the first innercatheter may include actuating a pull wire within the first innercatheter to deflect the bending region of the inner catheter. In someexamples deflecting the first inner catheter may include allowing thefirst inner catheter to assume a bent configuration (e.g., extending theinner catheter from out of the outer catheter, removing a stiffeningmember etc.).

As mentioned, the first inner catheter may be distally tapered from 3 Fror smaller to 14 Fr or larger. This taper may prevent or reduce damageto the tissue in combination with the engagement region between theinner and outer catheter, preventing fish-mouthing (e.g., separationbetween the inner and outer catheters at the distal connection betweenthe two, even while navigating through bent regions).

Any of these methods may include manually setting the first bend and/orthe second bend prior to advancing the distally first inner catheterthrough the transseptal puncture.

The methods described herein may include advancing a distally taperedinitial inner catheter through the transseptal puncture before advancingthe first inner catheter, wherein the initial inner catheter isannularly engaged to the outer catheter at a distal end region of theouter catheter, so that the outer catheter passes through thetransseptal puncture and into a left atrium.

In any of the methods described herein the method may use a single innercatheter and a single outer catheter. In some examples (as describedabove) a single outer catheter may be used with two or more innercatheters. For example, described herein are methods for percutaneousantegrade delivery and implantation of an aortic valve in a patient thatinclude: advancing an inner catheter that is distally tapered through atransseptal puncture, wherein a region of the inner catheter proximal toa distal end of the inner catheter is annularly engaged to an outercatheter at a distal end region of the outer catheter so that an outersurface of the inner catheter is flush with an outer surface of theouter catheter without a gap; deflecting the inner catheter within theleft atrium so that a distal end region of the inner catheter assumes afirst bend; advancing the outer catheter and the inner catheter so thatthe inner catheter is in the left ventricle; deflecting the innercatheter within the left ventricle so that the distal end region of theinner catheter assumes a second bend and the distal end region is bentin a way to direct the catheter system into the left ventricular outflowtract; advancing a guidewire out of the distal end of the inner catheterand across an aortic valve of the patient's heart; removing the first orsecond inner catheter, leaving the wire in place, and implanting areplacement aortic valve in the patient's heart through the outercatheter.

Any of these methods may include advancing the outer catheter and theinner catheter so that the inner catheter passes through an aortic valveof the patient's heart and at least partially into the ascending aortaover a guidewire.

In general, implanting the replacement aortic valve in the patient'sheart may include implanting the replacement valve through the outercatheter and over the guidewire.

Any of these methods may include advancing a second guidewire into theleft ventricle after the inner catheter has assumed the first bend.

For example, implanting the replacement aortic valve comprises advancinga transcatheter aortic valve replacement (TAVR) delivery system throughthe outer catheter.

As mentioned, the methods described herein may include expanding thetransseptal puncture with an expandable member on an outer surface ofthe inner catheter. The first bend may be at least about 30 degrees(e.g., between about 30-100 degrees, between about 30-90 degrees,between about 30-80 degrees, between about 30-70 degrees, between about30-60 degrees, between about 3-45 degrees, etc.). The second bend may beat least about 120 degrees (e.g., between about 120-190 degrees, betweenabout 120-180 degrees, between about 120-170 degrees, between about120-160 degrees, between about 120-150 degrees, between about 120-140degrees, etc.).

As mentioned above, deflecting the inner catheter may include actuatinga pull wire within the inner catheter. In some examples, deflecting theinner catheter comprises allowing the inner catheter to assume a bentconfiguration. The inner catheter may be distally tapered from 3 Fr orsmaller to 14 Fr or larger. Any of these methods may include manuallysetting the first bend and/or the second bend prior to advancing thedistally inner catheter through the transseptal puncture.

The methods described herein may include advancing a distally taperedinitial inner catheter through the transseptal puncture before advancingthe inner catheter, wherein the initial inner catheter is annularlyengaged to the outer catheter at a distal end region of the outercatheter, so that the outer catheter passes through the transseptalpuncture and into a left atrium.

As mentioned in some examples these methods may include the use of asingle outer catheter and two (or more) inner catheters that may beswapped (including by rapid exchange) at different points during theprocedure. For example, a method for percutaneous antegrade delivery andimplantation of an aortic valve in a patient may include: advancing afirst inner catheter that is distally tapered through a transseptalpuncture, wherein a region of the first inner catheter proximal to adistal end of the first inner catheter is annularly engaged to an outercatheter at a distal end region of the outer catheter so that an outersurface of the first inner catheter is flush with an outer surface ofthe outer catheter without a gap; deflecting the first inner catheterwithin the left atrium so that a distal end region of the first innercatheter assumes a first bend; advancing the outer catheter and thefirst inner catheter so that the first inner catheter is in the leftventricle; withdrawing the first inner catheter proximally from theouter catheter and inserting a second inner catheter through the outercatheter and into the left ventricle so that a region of the secondinner catheter proximal to a distal end of the second inner catheter isannularly engaged to the outer catheter at the distal end region of theouter catheter; deflecting the second inner catheter so that a distalend region of the second inner catheter assumes a second bend that isgreater than the first bend and a distal end of the second innercatheter is bent in a manner to allow passage of the catheter systeminto the left ventricular outflow tract; advancing a guidewire out ofthe distal end of the second inner catheter and across an aortic valveof the patient's heart; removing the first or second inner catheter,leaving the wire in place, and implanting a replacement aortic valve inthe patient's heart through the outer catheter.

The methods described herein may include advancing the second outercatheter and the inner catheter so that the second inner catheter passesthrough an aortic valve of the patient's heart and at least partiallyinto the ascending aorta before advancing the guidewire. Implanting thereplacement aortic valve in the patient's heart may comprise implantingthe replacement valve through the outer catheter and over the guidewire.

Any of these methods may include advancing a guidewire into the leftventricle after the first inner catheter has assumed the first bend. Insome examples, implanting the replacement aortic valve comprisesadvancing a transcatheter aortic valve replacement (TAVR) deliverysystem through the outer catheter. Any of these methods may includeexpanding the transseptal puncture with an expandable member on an outersurface of the first inner catheter. As described above, the expandablemember may comprise a balloon. Also, as described above, the first bendmay be at least about 30 degrees and the second bend may be at leastabout 120 degrees. Deflecting the first inner catheter may compriseactuating a pull wire within the first inner catheter. In some examplesdeflecting the first inner catheter comprises allowing the first innercatheter to assume a bent configuration. The first inner catheter may bedistally tapered from 3 Fr or smaller to 14 Fr or larger, as describedabove. Any of these methods may include manually setting the first bendand/or the second bend prior to advancing the distally first innercatheter through the transseptal puncture.

In some examples the method includes advancing a distally taperedinitial inner catheter through the transseptal puncture before advancingthe first inner catheter, wherein the initial inner catheter isannularly engaged to the outer catheter at a distal end region of theouter catheter, so that the outer catheter passes through thetransseptal puncture and into a left atrium.

As described herein, any of the catheters may have a varying stiffness.For example, the stiffness of the outer catheter and any of the innercatheters may decrease as the catheter extends away from a surgeon orother user. In some examples, any of the catheters may include a braidedliner, a spiral liner, or a combination thereof to change and/or controlthe stiffness of the catheter.

Any of the interchangeable inner catheters may include differentlyshaped distal tips that may be used to position and/or guide theguidewire within the patient. Alternatively, or in addition, any of theinterchangeable inner catheters may include a distally located dilationballoon.

In any of the methods described herein, the inner and outer cathetersmay be percutaneously introduced to the patient. The apparatus maypuncture and cross the atrial septum. A catheter may be advanced fromthe left atrium, into the left ventricle, and antegrade toward theaortic valve. From this position, a replacement aortic valve may beimplanted.

Any of the methods described herein may perform a percutaneous antegradedelivery and implantation of an aortic valve. Any of the methods mayinclude puncturing, using a guidewire, an atrial septum of a patient'sheart, advancing a catheter across the atrial septum into a left atriumof the patient's heart and advancing the catheter from the left atriumto a left ventricle. Further, any of the methods described herein mayinclude advancing, with the catheter, the guidewire through an aorticvalve of the patient's heart, positioning the catheter across an annulusof the aortic valve, and implanting a replacement aortic valve withinthe patient's heart.

In any of the methods described herein, the puncturing may include usinga radio-frequency device disposed on a distal end of the guidewire. Anyof the methods described herein may also include entering a femoralartery with the catheter and the guidewire prior to puncturing theatrial septum.

In any of the methods, the catheter may include a first inner catheterand an outer catheter, wherein the first inner catheter is concentricand detachably coupled to the outer catheter. Furthermore, the guidewiremay be concentric to, and enclosed by, the first inner catheter and theouter catheter.

In any of the methods described herein, advancing the catheter from theleft atrium to the left ventricle may include advancing the guidewirethrough a mitral valve of the patient's heart. In some examples,advancing the catheter from the left atrium to the left ventricle mayinclude replacing the first inner catheter with a second inner catheterhaving a curved distal tip, advancing the guidewire through the secondinner catheter with the curved distal tip, through a mitral valve, andinto the left ventricle, and withdrawing the second inner catheter fromthe outer catheter. In some aspects, the curved distal trip may have acurve of at least 30 degrees.

In any of the methods described herein, advancing the guidewire throughthe aortic valve may include using a third inner catheter having anacute angle curve distal tip having a curve of at least 120 degrees.Furthermore, positioning the catheter across the annulus of the aorticvalve further may include withdrawing the third inner catheter.

In any of the methods described herein, advancing the guidewire throughthe aortic valve may include advancing the guidewire in an antegradedirection into an aorta of the patient's heart. In any of the methods,positioning the catheter across the annulus of the aortic valve mayinclude positioning a distal tip of the outer catheter below the annulusof the aortic valve.

In any of the methods described herein, advancing the catheter acrossthe atrial septum may further include advancing a dilation balloon intothe atrial septum. In any of the methods described herein, advancing thecatheter across the atrial septum further may include advancing adilation balloon into the atrial septum. In addition, any of the methodsmay include inflating the dilation balloon to expand a puncture of theatrial septum; deflating the dilation balloon; and withdrawing thedilation balloon. In any of the methods described herein, the dilationballoon may be coupled to the catheter.

In any of the apparatuses described herein, the outer catheter mayinclude a coupler configured to engage with a lock ring disposed on thefirst interchangeable inner catheter. Any of the apparatuses may furtherinclude a second interchangeable inner catheter configured to bend atleast 30 degrees. Any of the apparatuses described herein may furtherinclude a third interchangeable catheter configured to bend at least 120degrees. In any of the apparatuses described herein, the firstinterchangeable inner catheter and the outer catheter may includeradiopaque markers.

The methods and apparatuses described herein may also or additionallyinclude a filter for capturing material during valve positioning anddeployment. The filter may be an expandable filter that may be attachedor affixed to a wire, such as a guidewire. Thus, any of the guidewiresdescribed herein may include a filter (“filter wire”). The filter may beheld collapsed by a sleeve that may be retracted proximally. The filtermay be deployed from a wire, such as the guidewire, that is extendeddistally antegrade beyond the valve being replaced or repaired. Forexample, in some variations, the method may include advancing theguidewire out of the distal end of the first or second inner catheterand across an aortic valve of the patient's heart, and the guidewire mayinclude a filter. Thus, any of these methods may include deploying afilter attached to the guidewire distally of the aortic valve.

Also described herein are guidewires that are configured to delivercontrast material from one or more side ports. These guidewires may beused in place of any of the guidewires described herein (including foruse with a filter as mentioned above). The guidewire may include anarray of side-facing ports or openings into a central lumen throughwhich contrast material may be injected. These guidewires may bereferred to herein as contrast-deploying guidewires. Acontrast-deploying guidewire may have a solid distal tip/distal endregion and may be hollow along the length of the contrast-deployingguidewire proximal to the distal tip region. The distal tip region ofthe contrast-deploying guidewire may extend any appropriate length(e.g., about 0.5 cm or less, about 1 cm or less, about 2 cm or less,about 3 cm or less, about 4 cm or less, about 5 cm or less, betweenabout 0.5-10 cm, between about 1-8 cm, between 0.5-7 cm, between about0.5-6 cm, between about 0.5-5 cm, etc.). Any number of side-openingports or holes may be used and may be arranged down the length of thecontrast-deploying guidewire. In some examples the ports or holes may bearranged on the same side of the contrast-deploying guidewire; in someexamples the ports or holes may be distributed around the width of thecontrast-deploying guidewire. For example, any of the methods describedherein may include delivering a contrast material out of one or moreside-facing ports of the guidewire.

As mentioned above, any of the methods and apparatuses described hereinmay include a deflector for deflecting chordae tendinae of the ventricleduring a procedure. For example, described herein are methods method forpercutaneous antegrade delivery and implantation of a valve in a patientcomprising: advancing a first inner catheter that is distally taperedinto a left atrium through a transseptal puncture, wherein a distalregion of the first inner catheter is flush with an outer catheter at adistal end region of the outer catheter; expanding an expandabledeflector to allow safe passage through the mitral valve withoutengagement of the chordae tendinae of the left ventricle; advancing theouter catheter and either the first inner catheter or a second innercatheter that has been exchanged for the first inner catheter, so thatthe first or second inner catheter is in a left ventricle whiledeflecting away from the chordae tendinae; advancing a guidewire out ofthe distal end of the first or second inner catheter and across a valveof the patient's heart; removing the first or second inner catheter,leaving the guidewire in place, and implanting a replacement valve inthe patient's heart through the outer catheter.

For example, a method for percutaneous antegrade delivery andimplantation of a valve in a patient may include: advancing a firstinner catheter that is distally tapered through a transseptal puncture,wherein a region of the first inner catheter proximal to a distal end ofthe first inner catheter is annularly engaged to an outer catheter at adistal end region of the outer catheter so that an outer surface of thefirst inner catheter is flush with an outer surface of the outercatheter without a gap; deflecting the first inner catheter within theleft atrium so that a distal end region of the inner catheter assumes afirst bend; expanding an expandable deflector to deflect away from thechordae tendinae of the left ventricle; advancing the outer catheter andeither the first inner catheter or the second inner catheter that hasbeen exchanged for the first inner catheter so that the first or secondinner catheter is in the left ventricle while deflecting away from thechordae tendinae; deflecting the first or second inner catheter withinthe left ventricle so that the distal end region of the first or secondinner catheter assumes a second bend and faces the patient's leftventricular outflow tract; advancing a guidewire out of the distal endof the first or second inner catheter and across an aortic valve of thepatient's heart; removing the first or second inner catheter, leavingthe wire in place, and implanting a replacement aortic valve in thepatient's heart through the outer catheter.

Any of these methods may include deflecting the first inner catheterwithin the left atrium so that a distal end region of the first innercatheter assumes a first bend.

Expanding the expandable deflector may include expanding the expandabledeflector on a guidewire extending through the first inner catheter or asecond inner catheter that has been exchanged for the first innercatheter. In some examples expanding the expandable deflector comprisesexpanding the expandable deflector on the first inner catheter or thesecond inner catheter that has been exchanged for the first innercatheter. Expanding the expandable deflector may include expanding theexpandable deflector on the second inner catheter that has beenexchanged for the first inner catheter.

Any of these methods may include, after advancing the guidewire out ofthe distal end of the first or second inner catheter: deflecting thefirst or second inner catheter within the left ventricle so that thedistal end region of the first or second inner catheter assumes a secondbend and faces the patient's left ventricular outflow tract. Forexample, the method may include deflecting away from the chordaetendinae of the left ventricle with the expandable deflector as thedistal end region of the first or second inner catheter assumes thesecond bend. In any of these methods, advancing the outer catheter andeither the first inner catheter or the second inner catheter may includeadvancing with the expandable deflector expanded.

An expandable deflector may be any appropriate deflector, includinginflatable deflector (e.g., balloons), mechanical deflectors (e.g.,struts, cages, mesh, etc.), or the like. For example, expanding theexpandable deflector comprises expanding a balloon. These methods andapparatuses may include one or more expandable deflectors. For example,the expandable deflector may be on the inner catheter, the outercatheter and/or a guidewire (or, more generally, a guide element). Asused herein a guide wire may include a wire, thin guide tube orcatheter, etc.

The expandable deflector may expand fully or partially and/or may beexpanded to a diameter that is appropriate for the anatomy (e.g., theventricle), such as to between about 1 cm and 5 cm. The mechanicaldeflector may have a rounded and/or smooth outer profile, which may helpavoid entrapment between the chordae tendinae and/or trauma to theinterior of the ventricle. For example the expandable deflector mayinclude an outer surface, which may be configured as a cover or sleeve.In some cases the expandable deflector may include mechanical ribs orstruts that may be covered by an elastic or elastomeric layer.

The expandable deflector may be expanded in in the ventricle (e.g., inthe left ventricle), including (but not limited to) expanding theexpandable deflector at the mitral orifice, e.g., prior to or just afterinserting through the mitral orifice/mitral valve.

As mentioned above, any of these methods may include applying electricalpacing to the patient's heart during the procedures described herein. Inany of these methods and apparatuses the outer catheter may beconfigured as a sheath (e.g., a pacing sheath), including a plurality ofelectrodes. For example, any of these methods may include applying apacing signal to the patient's heart from electrodes on the outercatheter (sheath) through which the inner catheter is inserted.

In any of these methods and apparatuses, implanting the replacementaortic valve may include advancing a transcatheter aortic valvereplacement (TAVR) delivery system through the outer catheter.

Also described herein are system for antegrade delivery of a replacementvalve that may be used in any of the methods described herein. Forexample, any of these apparatuses and methods may include an outercatheter configured as a sheath to receive the inner catheter, the outercatheter (sheath) comprising: an elongate body having a lumen configuredto receive the inner catheter, wherein the elongate body is configuredto extend from outside of a body to a left ventricular apex of theheart; a hub at a proximal end of the elongate body, the hub comprisinga hemostatic valve; a plurality of electrodes at a distal end region ofthe elongate body; a plurality of electrical connectors extendingproximally from the elongate body; and a plurality of conductor cables(which may form a bundle) extending from the plurality of electricalconnectors to the plurality of electrodes, so that each electricalconnector electrically connects to a corresponding electrode of theplurality of electrodes.

Thus, any of these methods and apparatuses may include an outer catheterconfigured as a sheath, e.g., a pacing or sheath adapted to quickly andeasily apply a pacing signal (a “quick pacing sheath”). Also describedherein are methods including any of these outer catheters (pacingsheaths) and a pacing controller configured to electrically couple tothe plurality of electrical conductors of the sheath, the pacingcontroller comprising one or more processors and a non-transitorycomputing device readable medium having instructions stored thereon thatare executable by the one or more processors to cause the pacingcontroller to apply a heart pacing stimulation from the plurality ofelectrodes.

Any of these apparatuses (e.g., systems) may also include an innercatheter wherein the inner catheter comprises: a distal end region thatis tapered, an engagement surface proximal to a distal end of the innercatheter, wherein the engagement surface is configured to sealinglycouple to a distal end region of the outer catheter (sheath) so that anouter surface of the first inner catheter is flush with an outer surfaceof the sheath without a gap. The inner catheters may be any of the innercatheters described herein. For example, as described above, the innercatheter may include a bend region between the engagement surface andthe distal end that is configured to assume a bend of greater than 120degrees.

The outer catheter (sheath) may include a side port at the proximal endof the elongate body, wherein the side port is in fluid communicationwith the lumen. The side port may be used to apply a fluid (e.g.,saline, etc.) or to withdraw fluid (e.g., blood).

The plurality of electrodes may be any appropriate electrodes. In someexamples the electrodes are ring electrodes arranged circumferentiallyaround the distal end region. In some examples the electrodes may bearranged in series along the distal end region. For example, theelectrodes may be arranged adjacent to each other along the longitudinallength of the elongate body of the sheath. For example, the electrodesof the plurality of electrodes may be separated from each other bybetween about 1 cm and 9 cm (e.g., between about 2 cm and 7 cm, betweenabout 4 cm and 6 cm, etc.).

The conductor cables may form a bundle that extends helically around theelongate body from the plurality of electrical connectors to theplurality of electrodes. This arrangement may be particularlyadvantageous to provide the apparatus a thin profile, while permittingflexibility for the elongate body.

The outer catheters configured as pacing sheaths described herein mayalso include a yoke coupled to the plurality of electrical connectors.

For example, a system for antegrade delivery of a replacement valve mayinclude: an outer catheter configured as a pacing sheath; an innercatheter comprising: a distal end region that is tapered, an engagementsurface proximal to a distal end of the inner catheter, wherein theengagement surface is configured to sealingly couple to a distal endregion of the outer catheter so that an outer surface of the first innercatheter is flush with an outer surface of the outer catheter without agap; wherein the outer catheter is configured to receive the innercatheter, the outer catheter comprising: an elongate body having a lumenconfigured to receive the inner catheter, wherein the elongate body isconfigured to extend from outside of a body to a left ventricular apexof the heart; a hub at a proximal end of the elongate body, the hubcomprising a hemostatic valve; a plurality of electrodes arranged alonga distal end region of the elongate body, wherein the plurality ofelectrodes is spaced from the distal end region by a standoff distance;a plurality of electrical connectors extending proximally from theelongate body; and a plurality conductor cables forming a bundleextending helically around the elongate body from the plurality ofelectrical connectors to the plurality of electrodes, so that eachelectrical connector electrically connects to a corresponding electrodeof the plurality of electrodes; and a pacing controller configured toelectrically couple to the plurality of electrical conductors of theouter catheter, the pacing controller comprising one or more processorsand a non-transitory computing device readable medium havinginstructions stored thereon that are executable by the one or moreprocessors to cause the pacing controller to apply a heart pacingstimulation from the plurality of electrodes.

Also described herein are methods including pacing, including methodsusing any of the pacing sheaths described herein. For example, a methodfor percutaneous antegrade delivery and implantation of a valve in apatient may include: advancing a first inner catheter that is distallytapered into a left atrium through a transseptal puncture, wherein adistal region of the first inner catheter is flush with an outercatheter at a distal end region of the outer catheter, further whereinthe outer catheter is configured as a pacing sheath having a pluralityof pacing electrodes; advancing the outer catheter and either the firstinner catheter or a second inner catheter that has been exchanged forthe first inner catheter, so that the first or second inner catheter isin a left ventricle; applying a pacing signal to the heart from theouter catheter to maintain a sinus rhythm of the heart; advancing aguidewire out of the distal end of the first or second inner catheterand across a valve of the patient's heart; removing the first or secondinner catheter, leaving the guidewire in place, and implanting areplacement valve in the patient's heart through the outer catheter

All of the methods and apparatuses described herein, in any combination,are herein contemplated and can be used to achieve the benefits asdescribed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features and advantages of the methods andapparatuses described herein will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,and the accompanying drawings of which:

FIG. 1A is an example transcatheter aortic valve replacement (TAVR)apparatus.

FIG. 1B is an enlarged view of the tip region of FIG. 1A showing anexpandable region in an expanded state.

FIG. 2A shows an example distal tip section of the TAVR apparatus ofFIG. 1A.

FIG. 2B shows example measurements associated with a distal tip section.

FIGS. 3A-3C shows an example distal tip region of the TAVR apparatus ofFIG. 1A.

FIGS. 4A-4C show example views of a midshaft section of the TAVRapparatus of FIG. 1A.

FIG. 5 shows a proximal view of the TAVR apparatus of FIG. 1A.

FIGS. 6A-6B show an example detailed views of an outer catheter of theTAVR apparatus of FIG. 1 . FIG. 6A shows an outer view; FIG. 6B shows asection through the apparatus of FIG. 6A.

FIG. 7 shows an example detail view of a transition area of an outercatheter.

FIG. 8 shows an example detail view of an inner catheter.

FIG. 9 shows an example inner view of an inner catheter.

FIG. 10 shows an example of a skived hypotube.

FIGS. 11A-11C show examples of an inner catheter, particularly under adilation balloon.

FIG. 12A shows an example inner catheter.

FIG. 12B shows a cross section of the inner catheter.

FIG. 13A shows an example distal end of any feasible inner catheter.

FIG. 13B shows another example distal end.

FIGS. 14A-14C show example shapes of a distal end of any feasible innercatheter.

FIG. 15A shows an example distal end of an outer catheter.

FIG. 15B shows an example distal end of a shaped outer catheter.

FIG. 16 shows possible cross-sections for an outer catheter.

FIGS. 17A-17D show example outer catheter shapes.

FIGS. 18A-18L show example steps of using the TAVR apparatus 00 of FIG.1A to introduce a replacement aortic valve into a patient.

FIG. 19 is a flowchart showing an example method for a transseptalimplantation of a replacement aortic heart valve.

FIGS. 20A and 20B illustrate an example of a system as described herein.

FIG. 21 shows an example of a method of using a system as described inFIGS. 21A-21B.

FIG. 22A shows one example of a method of using a system including afilter (e.g., filter wire or filter on a wire) that may be used with anyof the methods and apparatuses described herein.

FIG. 22B shows an example of a wire (e.g., guidewire) including infusionopenings along a region of the length of the wire.

FIGS. 23A-23C illustrate an example of a mitral valve centeringguidewire including an expandable deflector. This example is a 0.035″diameter centering guidewire having a J-tip. FIG. 23A shows a sideperspective view of the mitral valve centering guidewire. FIG. 23B showsa section through the view of FIG. 23A. FIG. 23C is a slightly enlargedview of the distal end region of the device of FIGS. 23A-23B with theexpandable deflector (e.g., balloon) in a collapsed configuration.

FIG. 24A illustrates the mitral valve centering guidewire of FIGS.23A-23C with the expandable deflector expanded and also includes theproximal end region.

FIG. 24B shows a section view of a proximal hub that may couple to theproximal end region of FIG. 24A (For inflating/deflating of theexpandable deflector).

FIGS. 25A-25D illustrate an example of a mitral valve centeringguidewire including an expandable deflector. This example is a 0.035″diameter centering guidewire having a straight tip. FIG. 25A shows aside perspective view of the mitral valve centering guidewire. FIG. 25Bshows a section through the view of FIG. 25A. FIG. 25C is a slightlyenlarged view of the distal end region of the device of FIGS. 25A-25Bwith the expandable deflector (e.g., balloon) in a collapsedconfiguration. FIG. 25D shows the expandable deflector of FIGS. 25A-25Cin an expanded configuration.

FIGS. 26A-26C illustrates an example of an inner catheter including anexpandable deflector. FIG. 26A shows a side perspective view of thedistal end region of the inner catheter.

FIG. 26B shows a section through the view of FIG. 26A. FIG. 26C is asection (section C-C′) transverse through the distal end region of FIG.26B.

FIGS. 27A-27B illustrate an example of a method of deflecting away fromthe chordae tendinae using a guidewire having an expandable deflector(similar to that shown in FIGS. 25A-25C).

FIGS. 28A-28B illustrate an example of a method of deflecting away fromthe chordae tendinae using an inner catheter having an expandabledeflector (similar to that shown in 26A-26C).

FIG. 29 illustrates one example of a method of replacing a valve asdescribed herein.

FIG. 30A illustrates one example of an outer catheter configured as apacing sheath as described herein.

FIG. 30B shows a transverse section through a distal end region of theouter catheter (pacing sheath) of FIG. 30A.

FIG. 30C shows a longitudinal section through a portion of the distalend region of the outer catheter of FIG. 30A (transverse to the sectionshown in FIG. 30B).

FIG. 31 is a section through the proximal region of the outer catheterof FIG. 30A.

DETAILED DESCRIPTION

The present disclosure describes apparatuses (e.g., device, systems,etc.) and methods for inserting, guiding, and implanting a replacement acardiac valve (e.g., aortic valve, mitral valve, etc.) using anantegrade approach. In some examples, a transcatheter valve replacementapparatus may include an outer catheter and at least one inner catheterthat may be detachably coupled together. The inner and outer cathetersmay have a decreasing stiffness as in a distal direction away from thesurgeon or handle of the apparatus. Any of the catheters may bepre-shaped or shaped by the surgeon. In addition, or in the alternative,any of the inner catheters may include a pre-shaped or shapable distaltip. Any of the apparatuses may include a dilation balloon to assist inenlarging a puncture or hole, such as an atrial septum puncture.

The apparatuses and methods described herein may include or may beconfigured for use with an expandable deflector to prevent entanglementwith the chordae tendinae. The expandable deflector may be integrated aspart of the inner catheter and/or guidewire. Any of these method andapparatuses may also include pacing of the heart during the procedure.In particular, any of these methods and apparatuses may include an outercatheter configured as a pacing sheath adapted to apply a pacing signal.

FIG. 1A is an example transcatheter aortic valve replacement (TAVR)apparatus 100. Although described herein as a system, the TAVR apparatus100 may be a device (e.g., an inner catheter). The TAVR apparatus 100may be configured as a system including an optional guidewire 110, anoptional hemostasis valve 120, an outer catheter 130, an inner catheter140, an optional 3-way stopcock 150, and an inflation bulb 160. Theinner catheter may include a dilation balloon 142, a distal tip 145.Other example TAVR apparatuses may include fewer, more, or differentcomponents than the TAVR apparatus 100 shown in FIG. 1A.

The TAVR apparatus 100 may be used for percutaneous delivery of areplacement valve using an antegrade approach via the left ventricle.The TAVR apparatus 100 may be well suited for percutaneous deliverythrough a variety of blood vessels, including but not limited to femoralarteries. In some examples, flexibility of the TAVR apparatus 100 mayvary from a proximal end (e.g., an end adjacent to the hemostasis valve120) to a distal end (e.g., an end adjacent to the distal tip 145). Forexample, the flexibility of the outer catheter 130 and/or the innercatheter 140 may vary from relatively stiff near the hemostasis valve120 to relatively flexible near the distal tip 145. The inner catheter140 may be interchangeable with other inner catheters having, forexample, differently shaped distal tips. These other inner catheters aredescribed in more detail in conjunction with FIGS. 18A-18L.

One or more guidewires may be included as part of the system. In someexamples, the guidewire 110 may be approximately 0.035 inches indiameter. In some other examples, the guidewire 110 may be any othergreater diameter, such as diameters greater than 0.035 inches(including, but not limited to 0.040, 0.045, 0.050, or any otherfeasible greater diameter). In some other examples, the guidewire 110may be any other lesser diameter, including diameters less than 0.035inches (including, but not limited to 0.030, 0.025, 0.020, or any otherfeasible smaller diameter). The guidewire 110 may be formed form anyfeasible material, including Nitinol.

The hemostasis valve 120 may provide a hemostatic barrier for anyattached catheter, including the outer catheter 130 and the innercatheter 140. The hemostasis valve 120 may attach to, and otherwise becoupled to the outer catheter 130. The inner catheter 140 may bedetachably coupled to the outer catheter 130. The hemostasis valve 120may also receive and direct air from the inflation bulb 160.Alternatively, or in addition, the hemostasis valve 120 may receive theguidewire 110. Although not shown, the guidewire 110 may travel throughone or more concentric lumens and may exit through the distal tip 145.The surgeon may manipulate the guidewire 110 to assist in positioning adilatation balloon 142 in a desired region. The inner catheter(s) mayinclude a rapid exchange monorail connection for a guidewire, as will bedescribed in greater detail herein.

The outer catheter 130 may be concentric with respect to the innercatheter 140. In some examples, the outer catheter 130 may include afirst section 133 and a second section 136. The first section 133 may bestiffer (e.g., less flexible) with respect to the second section 136.Construction of the outer catheter 130 is described in more detail inconjunction with FIGS. 4A-4C. The inner catheter 140 may be coupled tothe dilation balloon 142 and the inflation bulb 160. In some examples,the inner catheter 140 may slide easily with respect to the outercatheter 130. Introduction of air by the inflation bulb 160 may causethe dilation balloon 142 to expand. As shown, when not inflated thedilation balloon 142 may be collapsed and relatively close in size tothe guidewire 110. View 170 (FIG. 1B) shows a dilation balloon 143 inits expanded state.

The hemostasis valve 120 is shown coupled to the 3-way stopcock 150 byconnection tubing 155 through a flush port 157. The 3-way stopcock 150may enable any feasible liquid to be percutaneously introduced to thepatient through the hemostasis valve 120.

FIG. 2A shows an example distal tip section 200 of the TAVR apparatus100 of FIG. 1A. The distal tip section 200 may include a guidewire 210,an outer catheter 230 and an inner catheter 240. The guidewire 210, theouter catheter 230, and the inner catheter 240 may be examples of theguidewire 110, the outer catheter 130, and the inner catheter 140 ofFIG. 1A, respectively.

A transition 220 from the outer catheter 130 to the inner catheter 140may be relatively smooth and seamless. A smooth and seamless transition220 may aid in the insertion and manipulation of the TAVR apparatus 100and may prevent gaps that may catch on and/or scrape the lumen of thebody into which the system is inserted. The inner catheter 240 mayinclude a tapered element 245. The tapered element 245 enables a size(diameter) reduction from the transition 220 to the guidewire 110.

The inner catheter 240 may extend partially or wholly through the outercatheter 230. A distal tip 241 may be coupled to, or integral with theinner catheter 240. The distal tip 241 may have a low crossing profileto aid in maneuvering, manipulating, and inserting the TAVR apparatus100. In addition, in some examples the distal tip 241 may be highlyflexible. An expandable member (e.g., a dilation balloon 242) may bedisposed on the inner catheter 240. As shown, the dilation balloon 242may be collapsed and/or folded. Other expandable members may includeexpandable frames or struts, or the like.

FIG. 2B shows example measurements associated with a distal tip section250. The outer catheter may be, e.g., 28 French (Fr.). In this example,the exposed portion of the inner catheter may be between 4 and 5centimeters (cm). The dilation balloon may be between approximately 8and 12 millimeters (mm) and between approximately 10 and 20 mm inlength. The distal tip may taper from 4 Fr. to 3 Fr.

FIGS. 3A-3C show an example distal tip region 300 of the TAVR apparatus100 of FIG. 1A. The distal tip region 300 shown in FIG. 3A may includean outer catheter 330 and an inner catheter 340. The outer catheter 330and the inner catheter 340 may be examples of the outer catheter 230 andthe inner catheter 240 of FIG. 2 , respectively. The distal tip region300 may include a transitional area 320.

In some examples, a transition from the outer catheter 330 to the innercatheter 340 may be accomplished with an interference fit as shown inview 345 (FIG. 3B) of the transitional area 320. For example, amechanical interference may exist between the outer catheter 330 and theinner catheter 340 such that a tapered element 347 of the inner catheter340 may compress a distal portion of the outer catheter 330. In someexamples, the mechanical interference region may be 346.

In some examples, a transition from the outer catheter 330 to the innercatheter 340 may include a gap 355 as shown in view 350 (FIG. 3C) of thedistal tip region 300. The view 350 also shows a step 357 that may hideor occlude an outer edge of the outer catheter 330. The step 357 mayhelp smooth the transition between the outer catheter 330 and the innercatheter 340. In addition, the gap 355 may enable tolerance and/ormanufacturing variations between a variety of parts of the TAVRapparatus 100.

FIGS. 4A-4C show example views of a midshaft section of the TAVRapparatus 100 of FIG. 1A. A midshaft region 410 is shown. FIG. 4B showsa section through the device of FIG. 4A. The midshaft region 410includes an outer catheter 430 and an inner catheter 440. In someexamples, the outer catheter 430 may include a first section 431 and asecond section 432. In some examples, the outer catheter 430 may bestiffer (e.g., less flexible) proximally toward the hemostasis valve(not shown) and more flexible distally away from the hemostasis valve.In some examples, the first section 431 may be stiffer than the secondsection 432. A transition 434 between the first section 431 and thesecond section 432 may also be a transition between stiffness (e.g.,durometer) and/or internal reinforcements.

The inner catheter 440 may include a lock ring 441. The outer catheter430 may include a coupler 435. As the inner catheter 440 is insertedinto the proximal end of the outer catheter 430, the lock ring 441 mayslip into a space formed within the coupler 435. In this manner theinner catheter 440 may be captured and locked (e.g., detachably coupled)together with respect to the outer catheter 430.

A cross-sectional view 450 of the midshaft region 410 is shown whichincludes the outer catheter 430, the inner catheter 440, the lock ring441, and the coupler 435. In some examples, the outer catheter 430 maydecrease in diameter at the transition 434. For example, the firstsection 431 may be 2-3 Fr. larger than the second section 432. In someother examples, the first section 431 may be greater than 3 Fr. largerthan the second section 432. In still other examples, the first section431 may be less than 1 Fr. larger than the second section 432.

In some examples, the inner catheter 440 may include a rapid exchangeport 446 through which a guidewire 411 (which may be an example of theguidewire 110 of FIG. 1A) may pass therethrough.

View 460 in FIG. 4C shows detail associated with the coupler 435. Thecoupler 435 may be formed from stainless-steel, Nitinol, or any otherfeasible material. In some examples, the coupler 435 may be formed bylaser cutting feasible material. The coupler 435 may include a splitring 461 that enables the lock ring (not shown) to pass therethrough.The coupler 435 may also include a solid ring 462 that prevents furtherdistal travel of the lock ring. The lock ring may be captured in a space463 within the coupler 435. The coupler 435 may include two or moreflared tabs 465 that allow the coupler 435 to be welded or otherwiseattached to the outer catheter 430.

FIG. 5 shows a proximal view 500 of the TAVR apparatus 100 of FIG. 1A.The view 500 shows a guidewire 510, a hemostasis valve 520, an outercatheter 530, an inner catheter 540, and an inflation bulb 560 which maybe examples of the guidewire 110, the hemostasis valve 120, the outercatheter 530, the inner catheter 540, and the inflation bulb 160 of FIG.1A. The inflation bulb 560 may include an air inlet 561.

The hemostasis valve 520 may be coupled with the outer catheter 530, mayalso rotate with respect to the outer catheter 530. The hemostasis valve520 may include a seal 521 to prevent and/or limit the unintendedpassage of fluids from the outer catheter 530. A flush port 527 may becoupled to connection tubing 525. The connection tubing 525 may becoupled directly or indirectly to any feasible fluid source. Thus, theconnection tubing 525 may deliver a fluid to the flush port 527 and tothe outer catheter 530.

FIGS. 6A-6B show an example of detailed views of an outer catheter ofthe TAVR apparatus 100 of FIG. 1A. A first example view 610 may includea hemostasis valve 620 and an outer catheter 630, which may be examplesof the hemostasis valve 120 and the outer catheter 130 of FIG. 1A. Inaddition, the view 610 may show an outer catheter distal tip 640 and acoupler 635. The coupler 635 may be an example of the coupler 435 ofFIG. 4A.

The outer catheter 630 may include a first section 633 and a secondsection 636. As shown, there may be a transition 637 between the firstsection 633 and the second section 636. In some examples, the firstsection 633 may be stiffer relative to the second section 636. Forexample, the first section 633 may include a braid 634 that may offerstiffness, kink resistance, and resistance to torsion (e.g.,torqueability). In contrast, the second section 636 may include aspiral, or spiral-like reinforcement 638. The spiral or spiral-likereinforcement may offer less stiffness, with respect to the firstsection 633. However, the second section 636 may still have kinkresistance and resistance to torsion. In addition, the first section 633may be 30 F in diameter and the second section 636 may be 28 F indiameter. These diameters are exemplary and are not meant to belimiting. The first section 633 and the second section 636 may be anyfeasible diameter. In some examples, the diameter of the second section636 may be less than the diameter of the first section 633. A smallerdiameter may enable the second section 636 to be more flexible relativeto the first section 633.

The hemostasis valve 620 may be rotatable with respect to the outercatheter 630. In some examples, the hemostasis valve 620 may include ahub 621 that enables 360 degrees of rotation between a proximal and adistal portion of the hemostasis valve 620. The hemostasis valve 620 mayinclude a flush port 627.

The outer catheter distal tip 640 may include any feasible radiopaquematerial (e.g., a radiopaque marker) to enable the surgeon to visualizeand/or locate the distal end of the outer catheter 630 using fluoroscopyor other feasible or similar procedures. In some examples, the outercatheter distal tip 640 may include a tungsten loaded polymer, such as atungsten loaded Pebax®.

A second example view 650 shows example dimensions of the outer catheter630. In some examples, the second section of the outer catheter 630 maybe approximately between 30 and 40 cm in length. The inner diameter ofthe first section of the outer catheter 630 may be about 26 Fr. Theinner diameter of the second section of the outer catheter 630 may beabout 24 Fr. Furthermore, in some examples, an inner diameter of theouter catheter distal tip 640 may be about 23 Fr. (or a decrease ofabout 1 Fr. with respect to the inner diameter of the second section.The inner diameter 651 of the outer catheter 630 may include anyfeasible lubricious liner such as any feasible polytetrafluoroethylene(PTFE).

FIG. 7 shows an example detail view of a transition area 700 of an outercatheter. The transition area 700 may include a distal section 710 and aproximal section 720. A coupler 730 may be included in the distalsection 710. The coupler 730 may be an example of the coupler 435 ofFIG. 4A.

In some examples, the distal section 710 and/or the proximal section 720may include overlapping layers of coil and/or braid reinforcement toincrease kink resistance and resistance to torsion. In some examples,the distribution and/or type of coil and braid material may varyproximally to distally along the outer catheter. In this manner, thestiffness of the outer catheter may be made stiffer in the proximalsection 720 and less stiff in the distal section 710.

In some examples, the distal section 710 and/or the proximal section 720may include overlapping coils that are wound in opposite directions(clockwise and counterclockwise). This configuration of overlappingcoils may allow for increased flexibility and resistance to torsion.

In some examples a coil section from the distal section 710 may bewelded to a coil section from the proximal section 720 through thecoupler 730. For example, the coupler 730 may be integral to a coil ofthe distal section 710. Tabs 735 of the coupler 730 may be welded to acoil of the proximal section 720. Coils of the distal section 710 andthe proximal section 720 may be laser cut to control and/or modifyflexibility, stiffness, resistance to torsion, and the like.

FIG. 8 shows an example detail view of an inner catheter 800. The innercatheter 800 may include an inflation bulb 810, a proximal shaft 815, adistal shaft 820, a lock ring 830, a proximal tapered element 840, adistal tapered shaft 850, a dilation balloon 860, an inner shaft 880,and a distal tip 890.

The optional inflation bulb 810 may be used to inflate the optionaldilation balloon 860 through a lumen included or formed by the innercatheter 800. In some examples, the proximal shaft 815 may be formedfrom a stainless-steel shaft. In some other examples, the proximal shaft815 may be formed from any other feasible material. The distal shaft 820may include a braided inner layer and durable outer layer. The lock ring830, which may be an example of the lock ring 441, may be disposed onthe distal shaft 820.

The proximal tapered element 840 may be distal with respect to the lockring 830 and/or the distal shaft 820. The distal tapered shaft 850 mayextend beyond the proximal tapered element 840. As shown, the distaltapered shaft 850 may be enclosed and/or encircled by the dilationballoon 860. The dilation balloon 860 is shown in a possible inflatedstate. A radiopaque marker band 870 may be disposed on the distaltapered shaft 850 to assist the surgeon in locating the dilation balloon860 within the patient.

The inner catheter 800 may include a coil or braid reinforcedmicrocatheter inner shaft. The distal tip 890 may also include aradiopaque material (e.g., a radiopaque marker).

FIG. 9 shows an example inner (sectional) view of an inner catheter 900.The inner catheter 900 may include an inflation lumen 910, a skivedhypotube 920, and a rapid exchange port 930. The inflation lumen enablesair to be transferred from an inflation bulb to a dilation balloon. Theskived hypotube 920 may be adjacent to the inflation lumen 910. Theskiving may be variable as described in more detail in FIG. 10 .

The inner catheter 900 may also include the rapid exchange port 930 toallow the insertion of a guidewire. In some examples, the inner catheter900 may include an inner lumen 940. The inner lumen 940 may be coatedwith and/or include a lubricious coating of PTFE, for example.

FIG. 10 shows an example of a skived hypotube 1000. The skived hypotube1000 may be an example of the skived hypotube 920 for FIG. 9 . As shown,the skived hypotube 1000 may include a continuous linear skive 1010 thathas a more material proximally and less material distally. Thetransition of material from the proximal end to the distal end may besmooth and continuous. The continuous linear skive 1010 may provide moreflexibility toward the distal end of the skived hypotube 1000.

FIGS. 11A-11C show examples of an inner catheter, particularly under adilation balloon. The examples shown here may be examples of a distalend of the inner catheter 800 of FIG. 8 . FIG. 11A shows a first exampleof an inner catheter 1100. The inner catheter 1100 may include adilation balloon 1111 and a first tapered element 1112. As shown, thedilation balloon 1111 may be collapsed (not deployed or inflated). Theinner catheter 1100 may include a second tapered element 1113 that isdisposed substantially under the balloon region 1114. Notably, thesecond tapered element 1113 ends approximately near a region 1115 thatthe dilation balloon 1111 may contact the first tapered element 1112.

FIG. 11B shows a second example of an inner catheter 1120. The innercatheter 1120 may include a dilation balloon 1131, a first taperedelement 1132, and a second tapered element 1133. As shown the secondtapered element may be tapered under the balloon region 1134 and have aconstant outer diameter the rest of the length of the inner catheter1135.

FIG. 11C shows a third example of an inner catheter 1140. The innercatheter 1140 may include a dilation balloon 1151 and a tapered element1152. The tapered element 1152 may be thicker than the correspondingfirst tapered elements of FIGS. 11A and 11B. In some examples, aninflation lumen 1135 integral to the inner catheter 1140 may be thinnerthan corresponding inflation lumens of the inner catheter 1100 and 1120.

FIG. 12A shows an example inner catheter 1200. The inner catheter 1200may not include a dilation balloon. The inner catheter 1200 may includea handle 1210, a proximal shaft 1212, a distal outer shaft 1214, a lockring 1216, a tapered element 1218, an inner shaft 1220, and a distal tip1222.

The handle 1210 may enable the surgeon to insert the inner catheter 1200into an outer catheter (such as the outer catheter 130 of FIG. 1 , orany other feasible outer catheter). In some examples, the lock ring 1216may engage with a coupler of the outer catheter (not shown). Theproximal shaft 1212 may be formed from stainless-steel and be relativelystiff. The stiffness of the inner catheter 1200 may get progressivelymore flexible, the farther away to get from the handle 1210.

The distal outer shaft 1214 may be distal to the proximal shaft 1212. Insome cases, the distal outer shaft 1214 may cover the proximal shaft1212. The lock ring 1216 may be disposed on the distal outer shaft 1214.The inner catheter 1200 may be inserted into any feasible outercatheter. In some examples, the lock ring 1216 may engage with acorresponding coupler, such the coupler 435 of FIG. 4A.

The tapered element 1218 may be disposed on a distal end of the distalouter shaft 1214. The shape of the tapered element 1218 may enable theinner catheter 1200 to be inserted and enlarge blockages or punctures inlumens, although other uses are possible. Distal to the tapered element1218 is the inner shaft 1220. In some examples, the inner shaft 1220 maybe reinforced with a coil and/or a braid similar to as described withrespect to the outer catheter of FIGS. 6A-6B.

The distal tip 1222 may be distal with respect to the inner shaft 1220and the tapered element 1218. In some examples, the distal tip 1222 mayinclude a radiopaque material (e.g., a radiopaque marker) to enable thesurgeon to locate and track the inner catheter using fluoroscopy orother similar methods.

FIG. 12B shows a cross section 1250 of the inner catheter 1200. Thecross section 1250 may show a rapid exchange port 1260, a skivedhypotube 1262 and a guidewire lumen 1264. The rapid exchange port 1260may enable a guidewire to be inserted into the guidewire lumen 1264. Theskived hypotube may be an example of the skived hypotube 1000 of FIG. 10. The proximal shaft may be blocked (shown at 1266) since there is nodilation balloon that needs to be inflated.

FIG. 13A shows an example distal end 1300 of any feasible innercatheter. In some examples, the distal end 1300 may be the distaltapered shaft 850 of FIG. 8 , any of the tapered elements of FIG.11A-11C, the tapered element 1218 of FIG. 12A, or the like. The distalend 1300 may include a tapered element 1310, an embedded shape wire1320, and a guidewire lumen 1330. The embedded shape wire 1320 may belaminated and/or encapsulated within the tapered element 1310. In someexamples, the embedded shape wire 1320 may be a stainless-spring steel,Nitinol, or any other feasible material.

The distal end 1300 may be shaped into any feasible shape including acurve, as shown. The tapered element 1310 may be shaped, at least inpart, by the embedded shape wire 1320. In some examples, the embeddedshape wire 1320 may hold or retain the shape thereby causing the taperedelement 1310 to maintain a desired shape.

A cross-section 1340 of the distal end 1300 is shown. The cross section1340 shows a cross-section of the tapered element 1310, the embeddedshape wire 1320, and the guidewire lumen 1330. As shown, thecross-section of the embedded shape wire 1320 may be a flattened oval,however other cross-sections are possible. For example, thecross-section of the embedded shape wire 1320 may be round, flat/ribbon,square, or any other feasible shape.

In addition, or alternatively, the distal end 1300 may be shaped byapplication of heat. For example, the tapered element 1310 may be formedfrom or include a heat set polymer. The tapered element 1310 may beplaced into a heat set die to shape into a desired shape. In some otherexamples, the shape of the tapered element 1310 may be controlledthrough pull-wires. The pull wires may be anchored to the taperedelement 1310 and made available to the surgeon.

In some examples, the tapered element 1310 may include a stylet channel(not shown). Different semi-rigid shaped stylets could be insertedthrough a port causing the tapered element 1310 to conform to the shapeof the stylet.

FIG. 13B shows another example distal end 1350. Construction of thedistal end 1350 may be similar to the construction of the distal end1300, however in some examples the distal end 1350 may include ashapable embedded shape wire 1360. The shapable embedded shape wire 1360may be any feasible ductile material or metal that may be manual shapedby the surgeon or other user.

FIGS. 14A-14C show example shapes of a distal end of any feasible innercatheter. FIG. 14A shows a distal end 1400 that includes a taperedelement 1410 and a distal outer shaft 1411. In this example, the taperedelement 1410 may be shaped to have an approximate 30 degree bend. FIG.14B shows a distal end 1420 that includes a tapered element 1421 and adistal outer shaft 1422. In this example, the tapered element 1421 maybe shaped to have an approximate 90 degree bend. FIG. 14C shows a distalend 1430 that includes a tapered element 1431 and a distal outer shaft1432. In this example, the tapered element 1431 may be shaped to have anapproximate 120 degree bend.

The bends shown in FIGS. 14A-14C are meant to be exemplary andnon-limiting. In other implementations, the distal end of the innercatheter may have any feasible bend.

In some examples, the distal end of the inner catheter may be bent, butrelatively flexible. The guidewire may straighten the distal end, wheninserted. Conversely, when the guidewire is withdrawn from the distalend (from the tapered element), the distal end may revert to apre-determined shape.

FIG. 15A shows an example distal end of an outer catheter. The outercatheter may be any feasible outer catheter, including the outercatheter 130 of FIG. 1A. The outer catheter may include a shape-set coil1500. The shape-set coil 1500 may provide a pre-determined desired shapeto a distal end of the outer catheter. In some examples, the shape-setcoil 1500 may be Nitinol, stainless-steel, or any other feasiblematerial. In some examples, the shape-set coil 1500 could be heat set toa desired shape. In some examples, an initial shape of the shape-setcoil 1500 may be “more aggressive” (e.g., have more of a curvature orangle) because when the shape-set coil 1500 is laminated to form theouter catheter, some of the curvature or angle may be lost.

In some examples, the shape-set coil 1500 may be transferred to a dowel,shaft, or other form. A low durometer polymer and a thin liner may beapplied. The polymer and the liner may enable the shape-set coil 1500 todetermine, at least in part, the shape of the distal end of the outercatheter.

In some examples, a hybrid design may include the shape-set coil 1500and a non-shaped coil. The shape-set coil 1500 may be distally locatedwith respect to the non-shaped coil. In this manner, the distal portionof the outer catheter may be shaped while a proximal portion of theouter catheter may be relatively straight.

FIG. 15B shows an example distal end of a shaped outer catheter 1510. Asshown, the shaped outer catheter 1510 may include an unshaped coil 1520and a shaped coil 1530. The shaped outer catheter 1510 is shown in anunconstrained shape.

FIG. 16 shows possible cross-sections 1600 for an outer catheter. Asdescribed herein, a shape-set wire may be incorporated into,encapsulated, or laminated within the outer catheter. Cross-sections1600 includes an example cross-section 1610 with a rectangular (ribbon)shape-set wire 1611 as part of an outer catheter 1612. Examplecross-section 1620 includes a round shape-set wire 1621 as part of anouter catheter 1622. Example cross-section 1630 includes a flat (ribbon)shape-set wire 1631 as part of an outer catheter 1632.

In some examples, any of the cross-sections 1600 may include a heat-setpolymer to form all or part of the outer catheter. In some examples, anyof the cross-sections 1600 may include one more pull-wires to controlthe shape of the outer catheter. In some other examples, any of thecross-sections 1600 may include a stylet channel.

FIGS. 17A-D show example outer catheter shapes. FIG. 17A shows an outercatheter 1700 having 30 degree acute bend. FIG. 17B shows an outercatheter 1710 having a 30 degree smooth bend. FIG. 17C shows an outercatheter 1720 having a smooth 120 degree bend. FIG. 17D shows an outercatheter 1730 having a smooth 120 degree bend along with a distal tip1731 of an inner catheter 1732 having a 45 degree bend. The examples ofFIGS. 17A-17D are meant to be exemplary and not limiting. For example,any feasible combination of bends and/or bend angles are possible.

FIGS. 18A-18L show example steps of using the TAVR apparatus 100 of FIG.1A to introduce a replacement aortic valve into a patient. The stepsdescribed herein are merely exemplary and are not meant to be limiting.Other steps may be used, and in some cases, the steps may be performedin a different order. In particular, the FIGS. 18A-18L show variousinterchangeable inner catheters being used with the TAVR apparatus 100.

In FIG. 18A, a guidewire 1801 is introduced via a transseptal puncture(through an atrial septum) into the left atrium of a heart. For example,the guidewire 1801 may be percutaneously introduced into a patient'sfemoral artery using, at least in part, the TAVR apparatus 100. Theguidewire 1801 may be a 0.035-inch guidewire, however, in otherexamples, the guidewire 1801 may be other thicknesses or gauges. In someexamples, the transseptal puncture may be performed using aradio-frequency device disposed on or near a distal end of the guidewire1801.

Next, in FIG. 18B, a first interchangeable inner catheter 1802 and anouter catheter 1803 may be advanced to the transseptal puncture. Forexample, the first interchangeable inner catheter 1802 and the outercatheter 1803 may use the guidewire 1801 as a monorail guide. Forexample, the first interchangeable inner catheter 1802 may be introducedover the guidewire 1801 and positioned into the inferior vena cava (IVC)and the right atrium. The transseptal puncture may then be performed andthe first interchangeable inner catheter 1802 advanced through thepuncture. Note that a distal tip of the first interchangeable innercatheter 1802 may be relatively straight.

FIG. 18C shows an optional step of a balloon septostomy. In this step, adilation balloon 1804 may be advanced to the transseptal puncture andinflated to dilate (enlarge) the puncture. In some examples, thedilation balloon 1804 may have an inflated diameter of 6 mm. After theseptostomy, the dilation balloon 1804 may be removed. After thedilation, the dilation balloon 1804 may be deflated and withdrawn.

FIG. 18D shows the guidewire 1801 and the outer catheter 1803 in place.For example, the first interchangeable inner catheter 1802 may beunlocked from the outer catheter 1803 and then removed/withdrawn fromthe patient. As shown, the guidewire 1801 remains in the left atrium.

FIG. 18E shows an introduction of a second interchangeable innercatheter 1805 through the outer catheter 1803. The secondinterchangeable inner catheter 1805 may include a distal end and/or tipthat is curved beyond an angle of approximately 30 degrees. The secondinterchangeable inner catheter 1805 may be locked (through a lock ringand a coupler, for example) to the outer catheter 1803. The secondinterchangeable inner catheter 1805 may use the guidewire 1801 as amonorail guide.

FIG. 18F shows the second interchangeable inner catheter 1805 and theouter catheter 1803 advanced through the mitral valve and into the leftventricle. The second interchangeable inner catheter 1805 and the outercatheter 1803 may be guided by the guidewire 1801 (not shown).

Next in FIG. 18G, the second interchangeable inner catheter 1805 isunlocked from the outer catheter 1803 and withdrawn. The position of theguidewire 1801 and the outer catheter 1803 is maintained in the leftventricle.

FIG. 18H shows a third interchangeable inner catheter 1806 inserted andguided into the left ventricle. The third interchangeable inner catheter1806 may include a distal end and/or tip that is curved at or beyond anangle of approximately 120 degrees. In some examples, the thirdinterchangeable inner catheter 1806 may be inserted and locked into theouter catheter 1803. In some examples, the guidewire 1801 may optionallybe removed. The third interchangeable inner catheter 1806 may bepositioned so that a distal end of the third interchangeable innercatheter 1806 may be pointed towards the aortic valve.

FIG. 18I shows the guidewire 1801 advanced distally (antegrade, in thedirection of blood flow) through the left ventricle outflow tract (LVOT)and across the aortic valve. In some cases, the guidewire 1801 mayoptionally be a stiffer guidewire than guidewires used earlier in theprocedure (e.g., FIGS. 18A-18G).

FIG. 18J shows a first optional positioning of the third interchangeableinner catheter 1806 and the outer catheter 1803 within the patient'sheart. Note, the curve of the third interchangeable inner catheter 1806may be straightened, at least in part, by the guidewire 1801. As shown,the distal tip of the outer catheter 1803 may be below the annulus ofthe aortic valve.

FIG. 18K shows a second optional positioning of the thirdinterchangeable inner catheter 1806 and the outer catheter 1803 withinthe patient's heart. As shown, the distal tip of the outer catheter 1803may be advanced across the aortic valve.

FIG. 18L shows the TAVR apparatus 100 as the third interchangeable innercatheter 1806 is withdrawn. For example, the third interchangeable innercatheter 1806 may be unlocked from the outer catheter 1803 andcompletely withdrawn from the patient. In this position, the outercatheter 1803 is ready to deliver a replacement aortic valve. In somecases, if the distal tip of the outer catheter 1803 is across the aorticvalve, the surgeon may optionally withdraw or position the distal tip ofthe outer catheter 1803 below the aortic valve annulus to assist inpositioning and deployment of the replacement aortic valve.

Note that the position of any of the elements of the TAVR apparatus 100during any steps may be confirmed using any feasible techniquesincluding, but not limited to echocardiography, transesophagealechocardiography, aortic contrast injection, or the like. Positioning ofthe TAVR apparatus 100 may be enhanced by the embedded and/or includedradiopaque elements (e.g., radiopaque markers).

FIG. 19 is a flowchart showing an example method 1900 for a transseptalimplantation of a replacement aortic heart valve. Some examples mayperform the operations described herein with additional operations,fewer operations, operations in a different order, operations inparallel, and some operations differently. The method 1900 is describedbelow with respect to the TAVR apparatus 100 of FIG. 1A, however, themethod 1900 may be performed by any other suitable system or device.

The method 1900 may optionally include performing a transseptalpuncture. A TAVR apparatus may position a guidewire in the heart 1902.For example, the TAVR apparatus may introduce the guidewirepercutaneously into an artery, such as a femoral artery, although theuse of other arteries or veins is possible. In some examples, atransseptal puncture may be performed with a radio-frequency device. TheTAVR apparatus may be advanced through the atrial septum and positionedwithin the left atrium of the heart 1904. The inner and outer cathetersmay be advanced across the atrial septum. For example, the firstinterchangeable inner catheter may be coupled (locked) to the outercatheter and advanced over the guidewire using the guidewire as amonorail. In some cases, the first interchangeable inner catheter mayinclude a dilation balloon that may be used to expand or enlarge theseptal puncture. After dilation, the dilation balloon and/or the firstinterchangeable inner catheter may be removed. Optionally, the sameinner catheter may be used. Either the same or a different innercatheter may be deflected (e.g., bent, turned, angled, etc.) within thelet atrium so that that a distal end region of the inner catheterassumes a first bend 1904. The guidewire may then be directed distallyfrom the inner catheter and into the left ventricle.

Next, an inner and outer catheter may be advanced into the leftventricle 1906. For example, the inner and outer catheters may beadvanced through the atrial valve. In some examples, a secondinterchangeable inner catheter 1805 may be inserted and locked withinthe outer catheter 1803. Alternatively, the same inner catheter may beused (e.g. particularly where the inner catheter is steerable ordeflectable to greater than 120 degrees, as described below). In thismanner, the inner catheter (or a new inner catheter) and the outercatheter 1803 may be advanced into the left ventricle. Once in the leftventricle, the inner catheter (either the same inner catheter or a newinner catheter) may be deflected within the left ventricle so that thedistal end region of this inner catheter assumes a second bend(typically >120 degrees) and faces the left ventricular outflow tract1907.

The guidewire may then be advanced through the aortic valve 1908. Insome examples, the guidewire may be advanced through the aortic valveand into the aorta. Furthermore, in some examples, the inner catheterused in the previous step may be removed and replaced with anotherinterchangeable inner catheter.

The catheter may then be advanced and positioned across the annulus ofthe aortic valve 1910. For example, the inner catheter and the outercatheter may be positioned at or near the annulus of the aortic valve(or in some examples, across the aortic valve. In some examples, thedistal end of the outer catheter may be above the annulus of the aorticvalve. In some other examples, the distal end of the outer catheter maybe below the annulus of the aortic valve.

The guidewire (or a second guidewire having a different stiffness) maybe advanced out of the distal end of the inner catheter and across anaortic valve of the patient's heart.

A replacement aortic valve may then be implanted 1912. In some examples,the inner catheter may be unlocked and withdrawn from the outer catheterprior to the placement and implantation of the replacement aortic valve.

FIGS. 20A and 20B illustrate another example of a system 2000 forantegrade delivery of a replacement aortic valve. In this example, thesystem includes an outer catheter, and an inner catheter. The innercatheter is inserted into an outer catheter hub 2021 (as shown in FIG.20A) of the outer catheter 2030. The inner catheter 2040 in thisexample, is deflectable or bendable at a distal end region (shown inFIG. 20B). Deflection may be controlled by actuation of a deflectioncontrol 2056 on the inner catheter deflection handle 2055. In thisexample, moving the control forwards or backwards (shown by arrow 2057)may deflect the deflectable region 2061 of the inner member that isdistal to the coupling region 2063 to the outer catheter, but proximalto the distal (tapered) end 2065 of the inner catheter. In this example,the inner catheter, when coupled to the distal end of the outercatheter, is configured to deflect more than 120 degrees (e.g., in FIG.20B, the deflection is greater than 180 degrees, as shown by the arrow2058). Thus, the bend region 2061 between the engagement surface and thedistal end that is configured to assume a bend of greater than 120degrees. In some examples the bending may be actuated by a wire ortendon (e.g., a pull wire) that may extend through the inner catheter orthrough a wall of the inner catheter. Any appropriate actuatingmechanism may be used. For example, the catheters described herein maybe tendon driven catheters, magnetic navigation catheters, soft materialdriven catheters (e.g., shape memory effect catheters, steerableneedles, concentric tubes, conducting polymer driven catheters andhydraulic pressure driven catheters, etc.), and hybrid actuationcatheters. These catheters may have single sections or multiple sections

As shown in FIG. 20B, the distal end region of the inner catheter istapered 2065, and a proximal region of the inner catheter includes anengagement surface that is proximal to a distal end of the innercatheter, wherein the engagement surface forms part of the couplingregion 2063 that is configured to detachably and sealingly couple to adistal end region of the outer catheter 2030 so that an outer surface ofthe first inner catheter is flush with an outer surface of the outercatheter without a gap.

The example shown in FIGS. 20A-20B is just one example of an innercatheter; other examples may include smaller bending angles (e.g.,between 20-90 degrees, between 30-90 degrees, etc.). The outer cathetermay also be steerable.

FIG. 21 illustrates one example of a method using a system including asteerable inner catheter such as the one shown in FIGS. 20A-20B. in thisexample the system is shown with the inner and outer catheter extendingfrom the antegrade direction (e.g., through a septal opening, into theleft atrium, then the left ventricle) similar to that shown in FIGS.18A-18L. A relatively stiff guidewire 2110 is shown extending from theinner catheter 2140 and into the ascending aorta. The inner and outercatheters (coupled together as shown) may be advanced so that the outercatheter is adjacent to the aortic valve, but and the inner catheter maythen be removed, leaving the outer catheter in position to deliver(along with the guidewire) the replacement valve. As mentioned above, inany of these examples the outer catheter (which may also be referred toas an outer sheath) could be delivered either through the diseasedaortic valve or placed just proximal to the lower surface of the aorticvalve. Thus, the guidewire may be extended across the valve and thereplacement valve may be pushed across, without driving the sheathacross the valve.

Although the examples shown above and in FIGS. 18A-18L illustratemethods for replacing an aortic valve, similar techniques may be usedfor replacement of a mitral valve from an antegrade approach. Forexample, the same basic steps may be followed as described above, butthe outer and inner catheter may be advanced just to the mitral valve(e.g., without the need to deflect the inner catheter within the leftventricle. For example, a variation of FIGS. 18A-18G may be performed,leaving the distal end of the outer catheter adjacent to or through(e.g., beyond) the mitral valve. After delivery of the outer catheter(e.g., sleeve), a percutaneous mitral valve interventional device (e.g.,a mitral valve replacement device, a mitral valve repair device, a clip,etc.) may be advanced, positioned and deployed through outer catheter tothe mitral valve or the region proximate to the valve.

In general, the methods and apparatuses described herein may include oneor more features that enhance their use for replacement of a valve. Forexample, the inner catheter(s) may be configured for rapid exchange overthe guidewire (e.g., monorail) while the outer catheter does not, but isa full catheter. In general, the inner and outer catheters may sealinglylock onto each other as described, and the inner catheter may be steeredwhen locked (and extending distally from) the outer catheter so that theinner catheter may be freely steered, without interference from theouter catheter, while the outer catheter remains locked onto the innercatheter in a predictable and safe manner. In addition, the innercatheter may have a steeply tapered distal end (e.g., from 3 F to 20 Fin some examples); this tapered region may be relatively short (e.g.,may extend about 4 cm or less, about 3.5 cm or less, about 3 cm or less,about 2.5 cm or less, about 2 cm or less, about 1.5 cm or less, etc.)which may both prevent damage to the tissue and may allow maneuveringwithin the heart. Further, in the steerable inner catheters, thedeflecting region may stop proximally to the distal end of the innercatheter, so that the distal, highly flexible tip can track theguidewire. For example, the steerable region may end about 4-5 mm backfrom the distal tip. In general, the apparatuses and methods describedherein are configured to prevent scraping, which may otherwise damagethe vessel, and my cause the release of material (e.g., clot, plaque,calcified material, etc.) from the valve and/or wall(s) of the heart.

Filters

In general, any of the apparatuses and methods described herein mayinclude one or more filters that may be configured to be positioneddistally from the apparatus as it is positioned (or after it ispositioned) relative to the valve. The filter 2371 may be a filter wire,such as the one shown in FIG. 22A, which is configured to capture loosematerial during valve positioning and deployment. FIG. 22A illustratesthe placement of a filter 2371 as part of a system as described above.For example, a filter may be coupled to a wire 2375 (e.g., a 0.035″wire) and may be deployed into the ascending aorta, to catch debris fromvalve deployment and replacement. The filter may be self-expanding andmay be deployed as part of a guidewire (e.g., attached to theguidewire), or applied using (e.g., over) the guidewire, or adjacent tothe guidewire, and may be advanced into position in a collapsedconfigured with a sheath (not shown) over the self-expanding filter2271. Once in position distal to the distal end of the outer catheterand further antegrade, the filter sheath may be removed, and the filterdeployed as shown. Once deployed, the filter may capture any debrisarising from the procedure. Following the procedure, the filter may beremoved, e.g., re-sheathed, and withdrawn to remove any captured debris.

In some examples the filter wire may act as the 0.035′ guide wire todeliver the valve. In some examples, the filter may be deployed into theascending aorta and the sheath for the filter may be completely removed(e.g., pulled all the way out of the body) so that the replacement valve(e.g., TAVR valve) may be advanced over the filter wire. Once the valveis deployed, debris can be caught in the filter, which can be removed toretrieve the filter and any debris that was captured during theprocedure, in order to reduce the risk of embolic embolization to theintracerebral blood vessels of other more distal arteries.

Any appropriate wire for the filter wire and/or guidewire may be used.For example, in some cases the distal end of the wire may be, e.g., an A3J guidewire (e.g., the distal end may have a pre-set curve or shape)and may be any appropriate length. In some examples the filter regionmay be mounted or poisoned on a region that is proximal to the distalend. For example, the 15 cm proximal to tip of wire may include a filtermounted on wire. The filter may be, for example, an expandable nitinolfilter that may be delivered constrained by an outer sheath. Pulling thesheath may expand the filter (e.g., to 3 cm or larger diameter) and insome examples may contact a wall of the ascending aorta, e.g.,approximately 8 cm above valve but before first branch of the aorticarch). Thus, any of the methods and apparatuses described herein mayinclude the user of a filter (and antegrade filter) as described.

Alternatively, or additionally, the wires (e.g., filter wires, guidewires, etc.) may also be used to deliver contrast distally to theproximal aorta (e.g., a contrast-deploying guidewire). For example, anyof the wires described herein (e.g., guidewires, filter wires, etc.) maybe hollow and may include one or more distal openings (holes, slits,etc.) through which contrast may be applied. For example, any of theseapparatuses may include a wire to deliver contrast (and optionally todeliver and/or control a filter). In some examples the wire may includeone or more side holes in the wire, so that contrast may be deliveredfrom out of the side holes; for example, a syringe may be applied to theproximal end of the wire and contrast may be injected through the wire.The contrast may be delivered this way with or without the use of afilter. Alternatively, or additionally, contrast may be applied throughthe outer catheter to assist in the accurate placement of the valve.

FIG. 22B illustrates an example of a contrast-deploying guidewire 2377that includes a plurality of infusion holes 2379 arranged down a lengthof the side of the guidewire. The distal tip region of thecontrast-deploying guidewire may be solid (e.g., does not allow contrastmaterial to pass out of the distal end). Alternatively in some examplesthe distal tip region may be open instead or as well as the sideopenings. The length of the region of the contrast-deploying guidewirethat includes the plurality of openings may be, e.g., between 0.5 cm and10 cm (e.g., 0.5 cm or more, 0.75 cm or more, 1 cm or more, 1.5 cm ormore, 2 cm or more, 3 cm or more, 4 cm or more, 5 cm or more, betweenabout 0.5-10 cm, between about 0.5-8 cm, between about 0.5-7 cm, betweenabout 0.5-6 cm, between about 0.5-5 cm, between about 0.5-3 cm, etc.).The solid distal tip region of the contrast-deploying guidewire mayextend any appropriate length (e.g., about 0.5 cm or less, about 1 cm orless, about 2 cm or less, about 3 cm or less, about 4 cm or less, about5 cm or less, between about 0.5-10 cm, between about 1-8 cm, between0.5-7 cm, between about 0.5-6 cm, between about 0.5-5 cm, etc.).

The contrast-deploying guidewire may be formed of any appropriatematerial, including polymeric and/or metal (e.g., stainless steel,Nitinol, etc.) materials.

Expandable Deflectors

The methods and apparatuses for replacing a valve described herein mayinclude an expandable deflector to deflect the chordae tendinae in orderto prevent entangling any of the components (e.g., guidewire, innercatheter(s), outer catheter, etc.) in the chordae tendinae during theprocedure. For example any of the methods an apparatuses describedherein may include an expandible deflector that is configured to deflectthe chordae tendinae, to prevent damaging the valve and/or the chordaetendinae, including preventing cutting the chordae tendinae which mayotherwise result in mitral regurgitation.

An expandable deflector may include any expandable member, such as aballoon, basket, mesh, etc. that may be controllably expanded andcontracted. In some examples the apparatuses may include one or moreexpandable deflectors on a distal end region of the guidewire, an innercatheter, and/or an outer catheter. The expandable deflector may beexpended before, during or shortly after inserting the apparatus intothe ventricle (e.g., left ventricle) as described above, to displaceaway from the chordae tendinae, away from the apparatus and to preventthe apparatus from being caught between a chordae tendinae and the wallof the ventricle. In some examples the expandable deflector may act tocenter the apparatus within the mitral apparatus and/or the leftventricle.

FIGS. 23A-23C illustrate a first example of an apparatus including anexpandable deflector. FIG. 23A shows a guidewire 2300 including anexpandable deflector 2307 configured as a compliant balloon, thatextends over a distal region of the apparatus. In FIG. 23A the guidewire is configured as a mitral valve centering guidewire. The expandabledeflector 2307 may be expanded (as shown in FIG. 24A) to deflect awayfrom the chordae tendinae when in the ventricle. In FIG. 23A, theguidewire has a diameter of approximately 0.035″ and has a J-shaped tip(J-tip) 2305, which may be atraumatic and may include a radiopaquemarker. The expandable member may be formed of a compliant tube formingthe balloon that is coupled to the outer surface of the guidewire by apolymer jacket 2309. A more proximal outer surface region 2311 of theguidewire may be configured to have a textured surface that may provideadded grip for the inflation hub Tuohy region, shown in FIG. 24B.

As shown in the sectional view of FIG. 23B, the guidewire may be cut(e.g., laser-cut) in the distal end region 2313 to increase and/orenhance flexibility. The guidewire in this example may be formed of ahypotube 2315 that may be laser cut and coated, laminated, or otherwiseconfigured to seal the inner lumen, so that the inner lumen of thehypotube may be configured as an inflation lumen for inflating theexpandable deflector (e.g., balloon). For example, as shown in FIG. 23C,the guidewire may be a cut hypotube that is sealed by a laminatedpolymer jacket 2327. FIG. 23C shows a slightly enlarged view of theguidewire distal section shown in FIG. 23B. In FIG. 23C, the distal tip2317 is shown as an atraumatic distal tip that is attached (e.g.,soldered, welded, etc.) to a J-shaped distal region 2319 that mayinclude a shape-set inner core (e.g., nickel titanium inner core) tohave a J-shape. The distal end (J-shape) may be hermetically weldedbetween the hypotube and a core wire 2321, as shown in this example, Theexpandable deflector 2307 may be expanded by filling it with inflationfluid that may flow through and into the inner lumen of the guidewire.The distal end 2329 of the expandable deflector and the proximal end ofthe expandable deflector 2325 may be sealed to the guidewire as shown.

FIG. 24A shows an example of a guidewire apparatus 2400 similar to thatshown in FIGS. 23A-23C. As shown in FIG. 24A, the expandable member 2307may be expanded, e.g., to between about 4 mm and about 25 mm (e.g.,between about 12 mm and about 20 mm, etc.). FIG. 23C is a slightlyenlarged view of the device of FIGS. 23A-23B with the expandabledeflector (e.g., balloon) in a collapsed configuration. FIG. 24A alsoincludes a proximal end 2425 that may be coupled to a sealing removableinflation hub with a rotating Tuohy Borst seal 2424 (which may be usedas a handle). The hub in this example may include a positioning window2420 for aligning the guidewire, as well as an inflation port 2422(e.g., balloon inflation port). FIG. 24B shows an enlarged view of thishandle (inflation hub with a rotating Tuohy Borst seal 2424) of FIG.24A, including the Tuohy Borst seal 2430 sealed around the guidewire'sproximal end region.

FIGS. 25A-25D illustrate another example of a guidewire including anexpandable deflector 2507 (also configured as a compliant view in thisexample). As shown in FIG. 25A, the guidewire 2500 of FIGS. 25A-25D hasa straight distal end 2505 (shown as an atraumatic, radiopaque tip)rather than the J-shaped distal end region of FIGS. 23A-23C. The otherfeatures may be the same, however, including the polymer jacket region2509, and proximal textured surface 2511. As describe above for FIGS.23A-23C, the guidewire may be formed of a hypotube 2515 that may be cut(e.g., laser cut) to increase flexibility of the distal end region 2513.The guidewire 2500 may also include a machined platinum tip 2517, whichmay be an atraumatic tip, and a solder/glue joint 2520 coupling the sealtip to the hypotube. The expandable deflector may be inflated byinjecting a fluid 2523 through the hypotube to inflate the balloon 2507(as shown in FIG. 25D). The balloon may be seated in fluid communicationwith the lumen of the guidewire at a proximal balloon seal 2525 and adistal balloon seal 2529. As mentioned, the laser cut hypotube may besealed, e.g., by laminating a polymeric jacket over the laser cuthypotube 2527 as illustrated in FIG. 25C.

FIGS. 26A-26C illustrate an example of an inner catheter 2605 includingan expandable deflector 2607. As shown in FIG. 26A, the inner catheteray be engaged with an outer catheter 2603, as discussed above. Theexpandable deflector (balloon 2607) may be positioned at a distal endregion of the inner member and may be in fluid communication with aninflation lumen 2627, as shown in FIG. 26C. The distal end region of theinner catheter of FIGS. 26A-26C may be bendable or steerable using apull wire within a pull wire lumen 2621; the distal end of the pull wiremay be anchored 2617 within the distal end region, as shown in FIG. 26B.A guidewire 2611 may extend into and out of a guidewire lumen 2623.Thus, the inner catheter in this example may include a multi-lumen shaft2625.

In operation the chordae tendinae of the ventricle may be avoided aspart of any of the methods described herein for valve replacement. Forexample, FIGS. 27A-27B illustrate the use of a guidewire 2700 with anexpandable deflector 2707 similar to that shown in FIGS. 25A-25D. Theexpandable deflector 2707 may be inflated while at the mitral valve orjust proximal to the mitral valve, or in some examples just distal tothe mitral valve. In some examples inflation of the expandable deflectormay help advancing and centering of the guidewire, avoiding the chordaetendinae. For example, expansion of the expandable deflector may alsoallow the expandable deflector to be drawn into the ventricle and to thevalve during diastole, as it may act as a sail to and the flow of bloodwithin the ventricle may draw the expanded deflector forward. Theexpandable member may be deflated 2707′ once positioned, or in someexamples may be left inflated while performing other steps of themethod.

FIGS. 28A-28B illustrate the same operation using an inner catheter 2805(extending from an outer catheter 2803) including an expandabledeflector 2707 similar to that shown in FIG. 27A-27B. In FIG. 28B theexpandable deflector 2807′ is shown unexpanded.

In any of the figures shown herein, the dimensions may be illustrativeonly, and other dimensions may be used (e.g., +/−5%, 10%, 15%, 20%, 25%,50% or more).

FIG. 29 illustrates one example of a method of replacing a heart valveusing an expandable deflector. In general, the expandable deflector maybe used for any step of the procedure in which the apparatus ismaneuvering within the ventricle. In FIG. 29 , the procedure may beperformed while applying a pacing signal to the heart in order to createa paced rhythm 2901. In any of the methods described herein this may beperformed using an outer catheter configured as a pacing sheath, as willbe described in greater detail below.

The method 2900 may optionally include performing a transseptal puncture2903. As mentioned above, a TAVR apparatus may position a guidewire inthe heart. For example, the TAVR apparatus may introduce the guidewirepercutaneously into a vein or an artery, such as a femoral vein orartery, although the use of other arteries or veins is possible. In someexamples, a transseptal puncture may be performed with a radio-frequencydevice. The TAVR apparatus may be advanced through the atrial septum andpositioned within the left atrium of the heart. The inner and outercatheters may be advanced across the atrial septum 2905. For example,the first interchangeable inner catheter may be coupled (locked) to theouter catheter and advanced over the guidewire using the guidewire as amonorail. In some cases, the first interchangeable inner catheter mayinclude a dilation balloon that may be used to expand or enlarge theseptal puncture. After dilation, the dilation balloon and/or the firstinterchangeable inner catheter may be removed. Optionally, the sameinner catheter may be used. Either the same or a different innercatheter may be deflected (e.g., bent, turned, angled, etc.) within theleft atrium so that that a distal end region of the inner catheterassumes a first bend. The guidewire may then be directed distally fromthe inner catheter and into the left ventricle.

Prior to advancing the guidewire and/or inner catheter into theventricle, the system may prepare to deflect away from the chordaetendinea by expanding an expandable deflector 2907. As shown in FIG. 27Aor 28A the expandable deflector may be expanded (e.g., by inflating theballoon) at the mitral orifice. The expandable deflector may be on theguidewire (either straight or J-tip guidewire) and/or it may be on thedistal portion of the inner catheter. In some examples the innercatheter (or the inner catheter and guidewire) may be advanced into theventricle so that the expandable deflector is advanced first 2909; asmentioned above, the expanded expandable deflector may be advanced intothe ventricle, e.g., towards the ventricular apex, by the flow of blood.

Thus, the inner (and outer) catheter may be advanced into the leftventricle 2909 while deflecting away from the chordae tendinae. In someexamples, a second interchangeable inner catheter may be inserted andlocked within the outer catheter. Alternatively, the same inner cathetermay be used (e.g. particularly where the inner catheter is steerable ordeflectable to greater than 120 degrees). In this manner, the innercatheter (or a new inner catheter) and the outer catheter may beadvanced into the left ventricle. Once in the left ventricle, the innercatheter (either the same inner catheter or a new inner catheter) may bedeflected within the left ventricle so that the distal end region ofthis inner catheter assumes a second bend (typically >120 degrees) andfaces the left ventricular outflow tract 2911.

The expandable deflector may be used when maneuvering within theventricle, including steering or bending the inner catheter to face theoutflow tract, and used in order to prevent entangling of the chordae.The expandable deflector may be collapsed once the path through theventricle has been established.

A guidewire (the same or a different guidewire) may then be advancedthrough the aortic valve 2913. In some examples, the guidewire may beadvanced through the aortic valve and into the aorta. Furthermore, insome examples, the inner catheter used in the previous step may beremoved and replaced with another interchangeable inner catheter.

The catheter may then be advanced and positioned across the annulus ofthe aortic valve 2915. For example, the inner catheter and the outercatheter may be positioned at or near the annulus of the aortic valve(or in some examples, across the aortic valve. In some examples, thedistal end of the outer catheter may be above the annulus of the aorticvalve. In some other examples, the distal end of the outer catheter maybe below the annulus of the aortic valve, or even left closer to theleft ventricular apex.

The guidewire (or a second guidewire having a different stiffness) maybe advanced out of the distal end of the inner catheter and across anaortic valve of the patient's heart. A replacement aortic valve may thenbe implanted 2917. In some examples, the inner catheter may be unlockedand withdrawn from the outer catheter prior to the placement andimplantation of the replacement aortic valve.

Pacing Sheaths

In any of these methods a single vascular entry point may be used to dopacing. As mentioned above, any of the methods and apparatuses (e.g.,systems) described herein may include an outer catheter configured as apacing sheath that may simplify the operation of the procedure. Thepacing electrodes may be part of the distal portion of a sheath that maybe positioned at the left ventricular apex to allow escaped pacing orrapid pacing during valve implantation. A pacing controller may applypacing signals to provide pacing in case there is disruption of thesinus rhythm of the heart, and to avoid the need for a pacemakerinsertion. In general, an outer catheter configured as a pacing sheath(also referred to herein as a “rapid pacing sheath”) may include any ofthe features discussed above, including in particular the distal endregion for sealingly engaging with an inner catheter.

A pacing signal may be applied to the heart so that the heart may beelectrically paced to ensure pacing capture and to establish periodicityand predictability of the cardiac cycle during the procedure. One orboth of atrial and ventricular pacing may be applied. The pacing signalmay be controlled by a pacing controller that may be part of the pacingapparatus (e.g., pacing sheath). The controller may include a signalgenerator and one or more processors. The pacing apparatus may besuitably coupled to the patient and configured to provide a heart pacingsignal generated by the apparatus for cardiac stimulation, and also toallow rapid ventricular pacing during valve implantation.

As mentioned, the same sheath (outer catheter) may be used to insertmultiple inner catheters and may be used to provide electrical pacing.

For example, FIG. 30A illustrate one example of a pacing sheath asdescribed herein. This pacing sheath may be particularly advantageousbecause it may be adapted for rapid use with the retrograde systemsdescribed herein, including engaging with the catheter (e.g., one ormore inner catheter) while simplifying control of pacing and performanceof the valve replacement procedure. In FIG. 30A the pacing sheath 3000has an elongate body with a proximal end having a hub and a distal endhaving a plurality of electrodes for applying a pacing signal to theheart (e.g., to the apex of the ventricle).

The distal end region of the pacing sheath may include a plurality ofelectrodes 3006, 3008, 3010, 3012 at or near the distal tip. Theelectrodes may be circumferential, as shown in FIG. 30A, or they may bepositioned on just a portion of the circumference. The ring electrodesshown in FIG. 30A may be spaced apart by between about 1 and about 10 cm(e.g., between about 3 and 7 cm, etc.) in FIG. 30A the electrodes areseparated by about 5 cm, and are spaced about 2 cm from the distal endon the elongate body. In some examples, the distal tip of the apparatusshown in FIG. 30A may be configured to lock onto the outer diameter ofthe inner catheter, as described above. The electrodes may each becoupled to a helical lead electrically coupling the electrodes toconnectors (e.g., pins 3016, 3018, 3020, 3022) extending from a proximalend of the device. The connectors may couple to a controller (notshown), as described above. In some examples the leads may be helicallywound around the elongate body to extend the length of the sheath. Inthe example shown in FIG. 30A the leads comprise coiled conductor wires3014 that helically wind around the elongate body and couple to anover-molded yoke 3016 at the proximal end of the sheath. The leads(individual cables 3024) may be combined into a conductor cable bundle3032 that is coupled to the yoke 3016 and supports the connectors (e.g.,pins) for connecting to the controller. The conductive cables (e.g.,wires, leads, etc.) may be bundled together and extend togetherhelically around the length of the elongate body.

The proximal end of the sheath may also include a hub 3002 with ahemostasis valve for receiving and sealing onto the inner catheter (ormultiple, nested, catheters and/or guidewire(s). The hub may alsoinclude a side port 3004 that may be used to apply and/or removematerial through the central lumen 3015 of the sheath.

FIGS. 30B and 30C show sections through the distal end region of thesheath, illustrating one configuration of electrodes that may be used.In FIG. 30C the portion of the distal end region shown includes anexposed ring electrode 3008 that tis coupled to a conductive wire orlead 3038 that is insulated except for the exposed region 3042 incontact with the electrode. As mentioned, the conductive lead may behelically wound around the elongate body of the sheath. In this examplethe insulated wire is embedded and/or covered by an outer polymer jacketthat covers the wires 3040.

The elongate body of the sheath may be reinforced, e.g., by a coil orbraid 3044. The coil or braid may be supported by one or more layers,including being sandwiched between two or more layers. As shown in FIG.30C, the sheath also includes an inner or base polymeric jacket 3048that may insulate (and smooth) the inner wall of the lumen 3015 of thesheath. In some examples the sheath may also include a lubricious layer,such as a lubricious inner liner 3046. Alternatively, in some examplesthe base polymeric layer may be lubricious.

FIG. 31 shows an enlarged view of the proximal end of the pacing sheathof FIGS. 30A-30C. The hub 3002 includes a hemostasis valve, as mentionedabove, as well as a side port 3004, and a port for the bundle ofconductor cables 3032. The hub may also or alternatively be configuredas a handle. In FIG. 31 the conductor cables may be coupled to a yolk3015 supporting the individual connectors (e.g., pins 3016, 3018, 3220,3022).

It should be appreciated that all combinations of the foregoing conceptsand additional concepts discussed in greater detail below (provided suchconcepts are not mutually inconsistent) are contemplated as being partof the inventive subject matter disclosed herein and may be used toachieve the benefits described herein.

The process parameters and sequence of steps described and/orillustrated herein are given by way of example only and can be varied asdesired. For example, while the steps illustrated and/or describedherein may be shown or discussed in a particular order, these steps donot necessarily need to be performed in the order illustrated ordiscussed. The various example methods described and/or illustratedherein may also omit one or more of the steps described.

A person of ordinary skill in the art will recognize that any process ormethod disclosed herein can be modified in many ways. The processparameters and sequence of the steps described and/or illustrated hereinare given by way of example only and can be varied as desired. Forexample, while the steps illustrated and/or described herein may beshown or discussed in a particular order, these steps do not necessarilyneed to be performed in the order illustrated or discussed.

The various exemplary methods described and/or illustrated herein mayalso omit one or more of the steps described or illustrated herein orcomprise additional steps in addition to those disclosed. Further, astep of any method as disclosed herein can be combined with any one ormore steps of any other method as disclosed herein.

The processor as described herein can be configured to perform one ormore steps of any method disclosed herein. Alternatively, or incombination, the processor can be configured to combine one or moresteps of one or more methods as disclosed herein.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

In general, any of the apparatuses and methods described herein shouldbe understood to be inclusive, but all or a sub-set of the componentsand/or steps may alternatively be exclusive and may be expressed as“consisting of” or alternatively “consisting essentially of” the variouscomponents, steps, sub-components or sub-steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical valuesgiven herein should also be understood to include about or approximatelythat value unless the context indicates otherwise. For example, if thevalue “10” is disclosed, then “about 10” is also disclosed. Anynumerical range recited herein is intended to include all sub-rangessubsumed therein. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “X” is disclosed the “less than or equal to X” as well as “greaterthan or equal to X” (e.g., where X is a numerical value) is alsodisclosed. It is also understood that the throughout the application,data is provided in a number of different formats, and that this data,represents endpoints and starting points, and ranges for any combinationof the data points. For example, if a particular data point “10” and aparticular data point “15” are disclosed, it is understood that greaterthan, greater than or equal to, less than, less than or equal to, andequal to 10 and 15 are considered disclosed as well as between 10 and15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11,12, 13, and 14 are also disclosed.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A method for percutaneous antegrade delivery andimplantation of a valve in a patient, the method comprising: advancing afirst inner catheter that is distally tapered into a left atrium througha transseptal puncture, wherein a distal region of the first innercatheter is flush with an outer catheter at a distal end region of theouter catheter; expanding an expandable deflector to deflect away fromthe chordae tendinae of the left ventricle; advancing the outer catheterand either the first inner catheter or a second inner catheter that hasbeen exchanged for the first inner catheter, so that the first or secondinner catheter is in a left ventricle while deflecting away from thechordae tendinae; advancing a guidewire out of the distal end of thefirst or second inner catheter and across a valve of the patient'sheart; removing the first or second inner catheter, leaving theguidewire in place, and implanting a replacement valve in the patient'sheart through the outer catheter.
 2. The method of claim 1, furthercomprising deflecting the first inner catheter within the left atrium sothat a distal end region of the first inner catheter assumes a firstbend.
 3. The method of claim 1, wherein expanding the expandabledeflector comprises expanding the expandable deflector on a guidewireextending through the first inner catheter or a second inner catheterthat has been exchanged for the first inner catheter.
 4. The method ofclaim 1, wherein expanding the expandable deflector comprises expandingthe expandable deflector on the first inner catheter or the second innercatheter that has been exchanged for the first inner catheter.
 5. Themethod of claim 1, wherein expanding the expandable deflector comprisesexpanding the expandable deflector on the second inner catheter that hasbeen exchanged for the first inner catheter.
 6. The method of claim 1,further comprising, after advancing the guidewire out of the distal endof the first or second inner catheter: deflecting the first or secondinner catheter within the left ventricle so that the distal end regionof the first or second inner catheter assumes a second bend and facesthe patient's left ventricular outflow tract.
 7. The method of claim 6,further comprising deflecting away from the chordae tendinae of the leftventricle with the expandable deflector as the distal end region of thefirst or second inner catheter assumes the second bend.
 8. The method ofclaim 1, wherein expanding the expandable deflector comprises expandinga balloon.
 9. The method of claim 1, wherein expanding the expandabledeflector comprises expanding the expandable deflector at the mitralorifice.
 10. The method of claim 1, wherein advancing the outer catheterand either the first inner catheter or the second inner cathetercomprises advancing with the expandable deflector expanded.
 11. Themethod of claim 1, further comprising further comprising applyingelectrical pacing to the patient's heart from electrodes on the outercatheter.
 12. A method for percutaneous antegrade delivery andimplantation of a valve in a patient, the method comprising: advancing afirst inner catheter that is distally tapered through a transseptalpuncture, wherein a region of the first inner catheter proximal to adistal end of the first inner catheter is annularly engaged to an outercatheter at a distal end region of the outer catheter so that an outersurface of the first inner catheter is flush with an outer surface ofthe outer catheter without a gap; deflecting the first inner catheterwithin the left atrium so that a distal end region of the inner catheterassumes a first bend; expanding an expandable deflector to deflect awayfrom the chordae tendinae of the left ventricle; advancing the outercatheter and either the first inner catheter or the second innercatheter that has been exchanged for the first inner catheter so thatthe first or second inner catheter is in the left ventricle whiledeflecting away from the chordae tendinae; deflecting the first orsecond inner catheter within the left ventricle so that the distal endregion of the first or second inner catheter assumes a second bend andfaces the patient's left ventricular outflow tract; advancing aguidewire out of the distal end of the first or second inner catheterand across an aortic valve of the patient's heart; removing the first orsecond inner catheter, leaving the wire in place, and implanting areplacement aortic valve in the patient's heart through the outercatheter.
 13. The method of claim 12, wherein expanding the expandabledeflector comprises expanding the expandable deflector on a guidewireextending through the first inner catheter or a second inner catheterthat has been exchanged for the first inner catheter.
 14. The method ofclaim 12, wherein expanding the expandable deflector comprises expandingthe expandable deflector on the first inner catheter or the second innercatheter that has been exchanged for the first inner catheter.
 15. Themethod of claim 12, wherein expanding the expandable deflector comprisesexpanding the expandable deflector on the second inner catheter that hasbeen exchanged for the first inner catheter.
 16. The method of claim 12,further comprising deflecting away from the chordae tendinae of the leftventricle with the expandable deflector as the distal end region of thefirst or second inner catheter assumes the second bend.
 17. The methodof claim 12, wherein expanding the expandable deflector comprisesexpanding a balloon.
 18. The method of claim 12, wherein expanding theexpandable deflector comprises expanding the expandable deflector at themitral orifice.
 19. The method of claim 12, wherein advancing the outercatheter and either the first inner catheter or the second innercatheter comprises advancing with the expandable deflector expanded. 20.The method of claim 12, wherein implanting the replacement aortic valvecomprises advancing a transcatheter aortic valve replacement (TAVR)delivery system through the outer catheter.
 21. The method of claim 12,wherein the first bend is at least about 30 degrees.
 22. The method ofclaim 12, wherein the second bend is at least about 120 degrees.
 23. Themethod of claim 12, wherein deflecting the first inner cathetercomprises actuating a pull wire within the first inner catheter.
 24. Themethod of claim 12, wherein deflecting the first inner cathetercomprises allowing the first inner catheter to assume a bentconfiguration.
 25. The method of claim 12, wherein the first innercatheter is distally tapered from 3 Fr or smaller to 14 Fr or larger.26. The method of claim 12, further comprising manually setting thefirst bend and/or the second bend prior to advancing the distally firstinner catheter through the transseptal puncture.
 27. The method of claim12, wherein advancing the guidewire out of the distal end of the firstor second inner catheter and across an aortic valve of the patient'sheart comprises deploying a filter attached to the guidewire distally ofthe aortic valve.
 28. The method of claim 12, further comprisingapplying electrical pacing to the patient's heart from electrodes on theouter catheter, wherein the outer catheter is configured as a sheaththrough which the inner catheter is inserted.